Medications FDA Approved

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Drug Information (Updated 01/17/2003)

January 17, 2003

Current Drug Shortage: Thiola (tiopronin) 100 mg tablets
http://www.fda.gov/cder/drug/shortages/default.htm#Current

Meeting: International Conference on Harmonisation Meetings in Tokyo, Japan,
Including Progress on Implementation of the Common Technical Document and
Update on New Topics

DATE AND TIME: January 21, 10:30 a.m.

LOCATION: 5630 Fishers Lane, Rm. 1066, Rockville, MD.

CONTACT: Kimberly L. Topper, Center for Drug Evaluation and Research,
301-827-7001. The purpose of the meeting is to solicit public input prior to
the next Steering Committee and Expert Working Group meetings in Tokyo,
Japan, February 2003, at which discussion of the CTD and the future of ICH
will continue.


January 16, 2003

"The Buzz Takes Your Breath Away. Permanently." (Brochure)
HTML
http://www.fda.gov/cder/consumerinfo/buzz_brochure.htm

or PDF
http://www.fda.gov/cder/consumerinfo/fda_buzz_brochure.pdf

January 15, 2003

Draft Guidance Document: Estimating the Safe Starting Dose in Clinical
Trials for Therapeutics in Adult Healthy Volunteers [Word]
http://www.fda.gov/cder/guidance/3814dft.doc
or [PDF]
http://www.fda.gov/cder/guidance/3814dft.pdf

Guidance Document: Q1D Bracketing and Matrixing Designs for Stability
Testing of New Drug Substances and Products [Word]
http://www.fda.gov/cder/guidance/4985fnl.doc
or [PDF]
http://www.fda.gov/cder/guidance/4985fnl.PDF

Labeling Updates
http://www.fda.gov/cder/ogd/rld/LABELING_REVIEW_BRANCH.HTML

National Drug Code (NDC) Directory The National Drug Code (NDC) System was
originally established as an essential part of an out-of-hospital drug
reimbursement program under Medicare. The NDC serves as a universal product
identifier for human drugs. The current edition of the National Drug Code
Directory is limited to prescription drugs and a few selected OTC products.
http://www.fda.gov/cder/ndc/index.htm

National Drug Code Directory. Searchable Database
http://www.fda.gov/cder/ndc/database/default.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Betamethasone Dipropionate Cream, Altana Inc.

BUSULFEX (busulfan) Injection, Orphan Medical, Inc.

Dibenzyline (phenoxybenzamine HCl) Capsules, Wellspring Pharmaceutical
Corporation

Diovan HCT (valsartan/hydrochlorothiazide) Tablets, Novartis Pharmaceuticals
Corp.

Eloxatin (oxaliplatin) for Injection, Sanofi-Synthelabo, Inc.

Flecainide Acetate Tablets USP, Roxane Laboratories, Inc.

Lopid (gemfibrozil) Tablets, Pfizer, Inc.

Novantrone (mitoxantrone for Injection Concentrate), Serono, Inc.

Phentermine Hydrochloride Capsules USP, Amide Pharmaceuticals, Inc.

Phentermine Hydrochloride Capsules USP, Amide Pharmaceuticals, Inc.

Rimantadine Hydrochloride Tablets, Amide Pharmaceutical, Inc.

Carboplatin Injection USP, Pharmachemie B.V., Tentative Approval

Mirtazapine Tablets, Roxane Laboratories, Inc., Tentative Approval

Nefazodone Hydrochloride Tablets, Roxane Laboratories, Inc., Tentative
Approval

Patent Term Extension and New Patents Docket Number *95S-0117
http://www.fda.gov/cder/orange/docket.pdf

January 14, 2003

Drug Firm Annual Registration Status
http://www.fda.gov/cder/dfars/default.htm

News Along the Pike: Special Edition: Jim Morrison's Ombudsman's Corners
Drug Approval Reports
http://www.fda.gov/cder/pike/Special2002a.htm

Approval Times for Priority and Standard NMEs - Calendar Years 1993-2001
http://www.fda.gov/cder/rdmt/NMEapps93-02.htm

Approval Times for Priority and Standard NDAs - Calendar Years 1993-2002
http://www.fda.gov/cder/rdmt/NDAapps93-02.htm

Efficacy Supplements Approved in Calendar Year 2002
http://www.fda.gov/cder/rdmt/ESCY02AP.HTM

NDA Approvals for Calendar Year 2002
http://www.fda.gov/cder/rdmt/ndaaps02cy.htm

NDAs Approved in Calendar Years 1990-2002 by Therapeutic Potential and
Chemical Types
http://www.fda.gov/cder/rdmt/pstable.htm

NDAs Approved under Subpart H
http://www.fda.gov/cder/rdmt/accapp.htm

NDA and NDA Supplements Approved under Subpart H
http://www.fda.gov/cder/rdmt/accappr1.htm

Tentative Advisory Committee Meetings, CDER
http://www.fda.gov/cder/meeting/advisorycomyear.htm

January 13, 2003

FDA releases preliminary survey results on direct-to-consumer prescription
drug ads. FDA Talk Paper
http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01189.html

Investigational Human Drugs: Clinical Investigator Inspection List
http://www.fda.gov/cder/regulatory/investigators/default.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Cancidas (caspofungin acetate) Injection, Merck Research Laboratories

Dextrose and Potassium Chloride Injection, USP, Baxter Healthcare
Corporation

Doxycycline Tablets, Par Pharmaceutical, Inc.

Feldene (piroxicam) Capsules, Pfizer Pharmaceuticals Group

Gemzar (gemcitabine HCl) for Injection, Eli Lilly

Humalog (insulin lispro [rDND origin]) Injection, Eli Lilly

Hydrocodone Bitartrate and Acetaminophen Tablets USP, Able Laboratories,
Inc.

Imitrex (sumatriptan succinate) Injection, Glaxo Wellcome

Megace (megestrol acetate) Tablets, Bristol Myers Squibb Co.

Methotrexate Sodium Injection, Wyeth-Ayerst Laboratories

Monistat 3 Combination Pak, Personal Products

Oxilan, (Ioxilan) Injection, Guerbet LLC

Potassium Chloride in 5% Dextrose and Lactated Ringer's Injection, Baxter
Healthcare Corporation

Pre-Scrub II (4% chlorhexidine gluconate) Solution, Biomed Systems, Inc.

Prozac (fluoxetine HCI.) Pulvules, Eli Lilly & Company

RenAmin (amino acid) Injection, Baxter Healthcare Corporation

Singulair (Montelukast Sodium) Oral Granules, Merck Research Laboratories

Singulair (Montelukast Sodium) Tablets & Chewable Tablets, Merck Research
Laboratories

Strontium Chloride Sr-89 Injection USP, Bio-Nucleonics Pharma, Inc.

Tenormin (atenolol) Tablets, AstraZeneca Pharmaceuticals LP

Calcitriol Injection, Gensia Sicor Pharmaceuticals, Inc., Tentative Approval

Calcitriol Injection, Faulding Pharmaceutical Co., Tentative Approval

Calcitriol Injection, American Pharmaceutical Partners, Inc., Tentative
Approval

Tobramycin Solution for Inhalation, Roxane Laboratories, Inc., Tentative
Approval

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Drug Information (Updated 11/15/2002)

FDA and Pharmacia advise health care professionals about new warnings and
information in the product labeling of the drug Bextra (valdecoxib), a drug
approved for treatment of osteoarthritis, rheumatoid arthritis and
dysmenorrhea (menstrual pain). FDA Talk Paper
http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01170.html

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 11/14/2002)
http://www.fda.gov/cder/approval/index.htm

Abilify (aripiprazole) Tablets, Otsuka Pharmaceutical Co., Ltd.

Dextrose Injection USP, Baxter Healthcare

Doral (quazepam) Tablets, Wallace Laboratories

Glyburide Tablets USP (Micronized), Amide Pharmaceutical, Inc.

Ketalar (ketamine hydrocholride for injection), King Pharmaceuticals, Inc.

Mitozytrex (Mitomycin) Injection, USP, SuperGen, Inc.

Orap (pimozide) Tablets, Teva Pharmaceuticals

Remeron Soltab (mirtazapine) Orally Disintegrating Tablets, Organon Inc.

Valproate Sodium Injection, Bedford Laboratories

Loratadine Orally Disintegrating Tablets, Andrx Pharmaceuticals, Inc.,
Tentatve Approval


November 14, 2002

CDER Office Organization Charts

Center for Drug Evaluation Research Organizational Chart
http://www.fda.gov/cder/cderorg/cder.pdf

Office of Center Director
http://www.fda.gov/cder/cderorg/ocd.pdf

Office of Pharmaceutical Sciences
http://www.fda.gov/cder/cderorg/ops.pdf

Office of Pharmacoepidemiology and Statistical Science
http://www.fda.gov/cder/cderorg/OPSS.PDF

Office of New Drugs
http://www.fda.gov/cder/cderorg/OND.PDF

Electronic Submissions to the FDA, Randy Levin, MD, 5th Annual Electronic
Document Management Conference, 9/23/2002.
http://www.fda.gov/cder/regulatory/ersr/2002_09_23_tutorial_talk/index.htm

Impact of Regulations on Data Management Practice, Randy Levin, MD, DIA 12th
Annual European Clinical Data Management Conference, 11/5/2002.
http://www.fda.gov/cder/regulatory/ersr/2002_11_05_standards1/index.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 11/14/2002)
http://www.fda.gov/cder/approval/index.htm

Amcinonide Lotion USP, Altana Inc.

Amnesteem (Isotretinoin) Capsules USP, Genpharm Inc.

Amoxicillin and Clavulanate Potassium Tablets USP, Ranbaxy Laboratories Ltd.


BUSULFEX (busulfan) Injection, Orphan Medical, Inc.

Cerezyme (imiglucerase for injection), Genzyme Corporation

Edetate Disodium Injection USP, Apotex Corp.

Hydrocodone Bitartrate and Acetaminophen Tablets, Able Laboratories, Inc.

Intron (interferon alfa 2b) (REBETRON COMBINATION THERAPY), Schering
Corporation

Metformin Hydrochloride Tablets, Teva Pharmaceuticals
Torsemide Tablets, Par Pharmaceutical, Inc.

Omeprazole delayed-release Capsules (10 & 20mg dosage), IMPAX Laboratories,
Inc.

Omeprazole delayed-release Capsules (40mg dosage), IMPAX Laboratories, Inc.,
Tentative Approval

Rosters for the Antiviral and Dermatologic and Ophthalmic Drugs Advisory
Committees (updated)
http://www.fda.gov/cder/audiences/acspage/acslist1.htm

Warning Letters and Notice of Violation Letters to Pharmaceutical Companies
http://www.fda.gov/cder/warn/warn2002.htm


November 12, 2002

Approved Active Moieties to which FDA has Issued a Written Request for
Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic
Act
http://www.fda.gov/cder/pediatric/wrlist.htm

Pediatric Exclusivity Statistics as of October 31, 2002
http://www.fda.gov/cder/pediatric/wrstats.htm

Spectrum of Diseases/Conditions Written Requests as of October 31, 2002
http://www.fda.gov/cder/pediatric/specdis.htm

Studies Breakdown Report for Issued Written Requests as of October 31, 2002:
Pediatric Exclusivity
http://www.fda.gov/cder/pediatric/breakdown.htm


Drug Information (Updated 11/01/2002)

FDA and Roche have revised several sections of the safety labeling for
Accutane (isotretinoin). MedWatch Safety Information
http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#accuta

180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications;
Proposed rule; withdrawal. [TXT]
http://www.fda.gov/OHRMS/DOCKETS/98fr/110102a.htm

[PDF]
http://www.fda.gov/OHRMS/DOCKETS/98fr/110102a.pdf

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Bextra (Valdecoxib) Tablets, Pharmacia Corporation

Fragmin (dalteparin sodium injection), Pharmacia and Upjohn

Omeprazole delayed-release Capsules, Kremers Urban Development Co.

SecreFlo (secretin) Injection, ChiRhoClin, Inc.

ZINECARD (dexrazoxane) Injection, Pharmacia & Upjohn Company

On October 29, FDA approved over-the-counter marketing of Commit (nicotine
polacrilex lozenge), for adults 18 years of age and older, to reduce
withdrawal symptoms, including nicotine craving, associated with quitting
smoking.

On October 28, FDA has tentatively approved nefazodone hydrochloride
tablets, a generic version of serzone tablets, for treatment of depression.


October 31, 2002

Antiretroviral Drugs Using Plasma HIV RNA Measurements - Clinical
Considerations for Accelerated and Traditional Approval [Word]
http://www.fda.gov/cder/guidance/3647fnl.doc

or [PDF]
http://www.fda.gov/cder/guidance/3647fnl.pdf

CDER Organization Charts

Center for Drug Evaluation Research
Organizational Chart
http://www.fda.gov/cder/cderorg/cder.pdf

Office of Center Director
http://www.fda.gov/cder/cderorg/ocd.pdf

Office of Pharmaceutical Sciences
http://www.fda.gov/cder/cderorg/ops.pdf

Office of Pharmacoepidemiology and Statistical Science
http://www.fda.gov/cder/cderorg/OPSS.PDF

Office of New Drugs
http://www.fda.gov/cder/cderorg/OND.PDF

Drug Master Files
http://www.fda.gov/cder/dmf/index.htm

Drug Master Files
http://www.fda.gov/cder/dmf/index.htm

Immunotoxicology Evaluation of Investigational New Drugs [Word]
http://www.fda.gov/cder/guidance/4945fnl.doc

or [PDF]
http://www.fda.gov/cder/guidance/4945fnl.PDF

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Commit (nicotine polacrilex lozenge), GlaxoSmithKline

Dacarbazine for Injection USP, Bedford Laboratories

Dextroamphetamine Sulfate Tablets USP, KV Pharmaceutical

Dextroamphetamine Sulfate Tablets USP, KV Pharmaceutical

Hydrocodone Bitartrate and Acetaminophen Tablets USP, Mallinckrodt, Inc

Levaquin (levofloxacin) Tablets & Injection, R.W. Johnson Pharmaceutical
Research Institute

Testim 1% (testosterone gel), Auxilium Pharmaceuticals, Inc.

News Along the Pike; September-October 2002 HTML

http://www.fda.gov/cder/pike/septoct2002.htm

or PDF
http://www.fda.gov/cder/pike/septoct2002.pdf


October 30, 2002

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Amoxicillin & Clavulanate Potassium Tablets USP, TEVA Pharmaceuticals

Gabapentin Tablets, Purepac Pharmaceutical Co.

Pravachol (Pravastatin Sodium) Tablets, Bristol-Myers Squibb

Precose (acarbose) Tablets, Bayer Corporation

Vaseretic (Enalapril Maleate/Hydrochlorothiazide) Tablets & Vasotec
(Enalaprilat) IV, Merck


October 29. 2002

Center for Drug Evaluation Research Organizational Chart (Updated
10/13/2002, Posted 10/29/2002)
http://www.fda.gov/cder/cderorg/cder.pdf

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Amoxicillin & Clavulanate Potassium Tablets USP, TEVA Pharmaceuticals

Bumex (bumetanide) Tablets & Bumex (bumetanide) Injection, Hoffmann-La Roche
Inc.

Cosmegen (Dactinomycin) Injection, Merck & Company, Inc.

Ethosuximide Capsules, Banner Pharmacaps Inc.

Flecainide Acetate Tablets USP, Barr Laboratories, Inc.

Flecainide Acetate Tablets USP, Geneva Pharmaceuticals Technology Corp

Protonix (pantoprazole sodium) Delayed-Release Tablets & IV, Wyeth
Pharmaceuticals, Inc.

Zaroxolyn (metolazone) Tablets & Mykrox (metolazone) Tablets, Celltech
Pharmaceuticals, Inc.

Nefazodone Hydrochloride Tablets, Eon Labs, Inc., Tentative Approval

Nefazodone Hydrochloride Tablets, Mylan Pharmaceuticals, Inc., Tentative
Approval

Nefazodone Hydrochloride Tablets, Watson Laboratories, Inc., Tentative
Approval

Office of Center Director (Updated 10/13/2002, Posted 10/29/2002)
http://www.fda.gov/cder/cderorg/ocd.pdf

Office of Pharmaceutical Sciences (Updated 10/13/2002, Posted 10/29/2002)
http://www.fda.gov/cder/cderorg/ops.pdf

Office of Pharmacoepidemiology and Statistical Science (Updated 10/13/2002,
Posted 10/29/2002)
http://www.fda.gov/cder/cderorg/OPSS.PDF

Office of New Drugs (Updated 10/13/2002, Posted 10/29/2002)
http://www.fda.gov/cder/cderorg/OND.PDF


October 28, 2002

Patent Term Extension and New Patents Docket Number *95S-0117
http://www.fda.gov/cder/orange/docket.pdf


Drug Information (Updated 10/18/2002)

October 18, 2002

Public Service Announcements
http://www.fda.gov/cder/consumerinfo/DPAdefault.htm

Misuse of Prescription Pain Relievers
"Soon, all over-the-counter medicines will have one thing in common.
Simplicity."

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Amiodarone Hydrochloride Injection, Abbott Laboratories

Daypro ALTA (oxaprozin potassium) Tablets, Pharmacia Corporation

Inversine (mecamylamine hydrochloride) Tablets, Targacept, Inc.

Nitro-Dur (nitroglycerin) Transdermal Infusion System, Schering Corporation

Propafenone Hydrochloride Tablets, Vintage Pharmaceuticals, Inc.

Tequin (Gatifloxacin) Tablets & Injection, Bristol-Myers Squibb

Prednisolone Sodium Phosphate Oral Solution, Hi-Tech Pharmacal Co., Inc.,
Tentative Approval

Zocor (simvastatin) Tablets, Merck & Co., Inc.


October 17, 2002

Approved Active Moieties to which FDA has Granted Exclusivity for Pediatric
Studies under Section 505A of the Federal Food, Drug, and Cosmetic Act
http://www.fda.gov/cder/pediatric/exgrant.htm

Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAs [Word]
http://www.fda.gov/cder/guidance/4786fnl.doc
or [PDF]
http://www.fda.gov/cder/guidance/4786fnl.PDF

Example Drug Facts Labels
Acetaminophen 120 mg in a Suppository Dosage Form [PDF]
http://www.fda.gov/cder/guidance/4786LA7.PDF

Acetaminophen 325 mg in a Suppository Dosage Form [PDF]
http://www.fda.gov/cder/guidance/4786LA8.PDF

Acetaminophen 650 mg in a Suppository Dosage Form [PDF]
http://www.fda.gov/cder/guidance/4786LA9.PDF

Cimetidine 200 mg in a Tablet Dosage Form [PDF]
http://www.fda.gov/cder/guidance/4786LA6.PDF

Clemastine Fumerate 1.34 mg in a Tablet Dosage Form [PDF]
http://www.fda.gov/cder/guidance/4786LA12.PDF

Doxylamine Succinate 25 mg Tablet Dosage Form [PDF]
http://www.fda.gov/cder/guidance/4786LA14.PDF

Ibuprofen 200 mg in a Tablet/Capsule Dosage Form [PDF]
http://www.fda.gov/cder/guidance/4786LA1.PDF

Loperamide HCl in a Liquid Dosage Form [PDF]
http://www.fda.gov/cder/guidance/4786LA4.PDF

Loperamide HCl in a Tablet/Caplet Dosage Form [PDF]
http://www.fda.gov/cder/guidance/4786LA5.PDF

Miconazole Nitrate Vaginal Products [PDF]
http://www.fda.gov/cder/guidance/4786LA11.PDF

Minoxidil Topical Solution 2% for Men and Women [PDF]
http://www.fda.gov/cder/guidance/4786LA2.PDF

Minoxidil Topical Solution 5% for Men [PDF]
http://www.fda.gov/cder/guidance/4786LA3.PDF

Naproxen Sodium 220 mg in a Tablet/Caplet/Gelcap Dosage Form [PDF]
http://www.fda.gov/cder/guidance/4786LA10.PDF

Pseudoephedrine HCl Extended-Release Tablets 120 mg [PDF]
http://www.fda.gov/cder/guidance/4786LA13.PDF

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Amiodarone Hydrochloride Injection, Faulding Pharmaceutical Co.

Amiodarone Hydrochloride Injection, Bioniche Pharma Ltd.

Amiodarone Hydrochloride Injection, Ben Venue Laboratories, Inc.

Amiodarone Hydrochloride Injection, American Pharmaceutical Partners, Inc.

Amiodarone Hydrochloride Injection, Bedford Laboratories

Avandamet (rosiglitazone maleate/metformin HCl) Tablets, GlaxoSmithKline

Idamycin (idarubicin hydrochloride) Injection USP, Pharmacia & Upjohn
Company

Mentax TC (Butenafine HCI) Cream, Bertek Pharmaceuticals, Inc.

Tizanidine Hydrochloride Tablets, CorePharma LLC

Welchol (colesevelam hydrochloride) Tablets, Sankyo Pharma Inc.

Zithromax TRI-PAK (azithromycin) Tablets, Pfizer Inc.

Zithromax (azithromycin for injection), I.V., Pfizer, Inc.

Zithromax (Azithromycin) Capsules, Single Dose Packet & Tablets, Pfizer Inc.


Zithromax (azithromycin) Oral Suspension and Tablets, Pfizer Inc.

New Drug Approval Reports
http://www.fda.gov/cder/rdmt/default.htm

Fast Track Designated Products Approved since 1998
http://www.fda.gov/cder/rdmt/internetftap.htm

CDER Response to Request for Fast Track Designation
http://www.fda.gov/cder/rdmt/internetftstats.htm

Reference Listed Drugs: Drug Labeling Updates-August
http://www.fda.gov/cder/ogd/rld/rld_labeling_approved_august_2002.htm


October 16, 2002

Office of Drug Safety web site
http://www.fda.gov/cder/Offices/ODS/default.htm

Tentative Advisory Committee Meetings, CDER
http://www.fda.gov/cder/meeting/advisorycomyear.htm

October 15, 2002

Office of Generic Drugs
Approvals (10/15/2002)
http://www.fda.gov/cder/ogd/approvals/AP0802.htm

First-Time Generics (10/15/2002)
http://www.fda.gov/cder/ogd/approvals/1stgen0802.htm

Tentative Approvals (10/15/2002)
http://www.fda.gov/cder/ogd/approvals/TA0802.htm


Drug Information (Updated 10/04/2002)

October 4, 2002

Approved Drug Products with Therapeutic Equivalence Evaluations-22nd Edition
(Cumulative Supplement-8)
http://www.fda.gov/cder/orange/supplement/cspreface.htm
[Information and Data Files
http://www.fda.gov/cder/orange/obreadme.htm

Approved Drug Products with Therapeutic Equivalence: Query
http://www.fda.gov/cder/ob/default.htm

Approved Drug Products with Therapeutic Equivalence Evaluations Monthly
Additions and Deletions (August)
http://www.fda.gov/cder/rxotcdpl/pdpl_200208.htm

FDA and Roche strengthened the contraindications, warnings, precautions, and
adverse reactions sections of the Lariam (mefloquine hydrochloride) label.
Lariam is used for the treatment of mild to moderate acute malaria, and to
prevent malaria infections. FDA Safety Information.
http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#lariam

Generic Pharmaceutical Association Fall Technical Workshop: The Generic
Pharmaceutical Industry: Regulatory and Scientific Challenges. October
15-16, 2002. Agenda and registration
http://www.gphaonline.org/pdf/2002-technical-workshop.pdf

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Agenerase (amprenavir) Capsules and Oral Solution, GlaxoSmithKline

Cefuroxime Axetil Tablets USP, Apotex Corp.

Entocort EC (Budesonide) Capsules, AstraZeneca LP

Humulin Mixture 70/30 Injection, Eli Lilly and Co.

Lariam (mefloquine hydrochloride) Tablets, Hoffman-LaRoche, Inc.

ProStep (nicotine transdermal system), Elan Drug Delivery, Inc.

Zagam (sparfloxacin) Tablets, Mylan Pharmaceuticals Inc.

Ziagen (abacavir sulfate) Tablets and Oral Solution, GlaxoSmithKline

Patent Term Extension and New Patents Docket Number *95S-0117
http://www.fda.gov/cder/orange/docket.pdf

Survey of Drug Products Compounded by a Group of Community Pharmacies:
Finding from a Food and Drug Administration Study.
http://www.fda.gov/cder/pharmcomp/communityPharmacy/default.htm


October 3, 2002

CDER Live! PDUFA III: Building on Success. A joint production of the Center
for Drug Evaluation and Research and the Drug Information Association,
November 5, 2002. [PDF] (10/3/2002)
http://www.diahome.org/Content/Events/02055.pdf

National Drug Code (NDC) Directory . The National Drug Code (NDC) System
was originally established as an essential part of an out-of-hospital drug
reimbursement program under Medicare. The NDC serves as a universal product
identifier for human drugs. The current edition of the National Drug Code
Directory is limited to prescription drugs and a few selected OTC products.
http://www.fda.gov/cder/ndc/index.htm

National Drug Code Directory Searchable Database
http://www.fda.gov/cder/ndc/database/default.htm

Warning Letters and Notice of Violation Letters to Pharmaceutical Companies

http://www.fda.gov/cder/warn/warn2002.htm


October 2, 2002

Bioresearch Monitoring Information System File
http://www.fda.gov/cder/foi/special/bmis/index.htm

Draft Guidance: Nonclinical Studies for Development of Pharmaceutical
Excipients [Word]
http://www.fda.gov/cder/guidance/3812dft.doc
or [PDF]
http://www.fda.gov/cder/guidance/3812dft.pdf

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Paxil (paroxetine hydrochloride) Tablets, GlaxoSmithKline

Vumon (teniposide) for Injection Concentrate, Bristol-Myers Squibb Company

Wellbutrin (bupropion hydrochloride) Immediate-Release & Sustained-Release
Tablets, GlaxoSmithKline

Standard Costs for Components of the Process for the Review of Human Drug
Applications
http://www.fda.gov/cder/pdufa/pdufa_costs.htm


October 1, 2002

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Aciphex (Rabeprazole Sodium) Delayed-Release Tablets, Eisai Inc.

AVAGE (tazarotene) Cream, Allergan, Inc.

Glucovance (Glyburide and Metformin HCL) Tablets, Bristol-Myers Squibb

Hypaque-Cysto (brand of diatrizoate meglumine), Amersham Health

Idamycin (idarubicin hydrochloride) Injection USP, Pharmacia & Upjohn
Company

Inspra (eplerenone) Tablets, G.D. Searle LLC

Lisinopril Tablets USP, Torpharm

ProHance (gadoteridol) Injection, Bracco Diagnostics, Inc.

Protopam (pralidoxime chloride) for Injection, Wyeth Pharmaceuticals

Remeron (mirtazapine) Tablets, Organon Inc.

Thyrolar (liotrix) Tablets, Forest Laboratories, Inc.

Ranitidine Capsules, TEVA Pharmaceuticals USA, Approvable


Drug Information (Updated 9/27/2002)

September 27, 2002

Advisory Committee Roster for Oncologic Drugs (updated)
http://www.fda.gov/cder/audiences/acspage/oncologicroster1.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

ADRIAMYCIN PFS (doxorubicin hydrochloride injection), Pharmacia & Upjohn
Company

Alburterol Extended-release Tablets, Sidmak Laboratories, Inc.

Augmintin XR (Amoxicillin/Clavulanate Potassium) Extended-release Tablets,
GlaxoSmithKline

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine
Sulfate, and Amphetamine Sulfate Tablets, Eon Labs, Inc.

Ranitidine Tablets USP, Geneva Pharmaceuticals, Inc.

Sotalol Hydrochloride Tablets, Torpharm

Ticlopidine Hydrochloride Tablets, Caraco Pharmaceutical Laboratories, Ltd.

Videx EC (didanosine) Delayed Release Capsules, Bristol-Myers Squibb

Clomipramine Hydrochloride Capsules, Drug Approval Package

Cholestyramine for Oral Suspension, Drug Approval Package

Cefuroxime Injection, Drug Approval Package

Carisoprodol, Aspirin and Codeine Phosphate Tablets USP

Patent Term Extension and New Patents Docket Number *95S-0117
http://www.fda.gov/cder/orange/docket.pdf

Sterile Drug Products Produced by Aseptic Processing: Draft
http://www.fda.gov/cder/dmpq/aseptic-cp.pdf


September 26, 2002

Guidance Agenda: Guidances CDER is Planning to Develop During FY 2003
http://www.fda.gov/cder/guidance/guidance-agenda.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Aminocaproic Acid Syrup USP, Drug Approval Package

Atracurium Besylate Injection, Drug Approval Package

Atracurium Besylate Injection, Drug Approval Package

Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules USP, Drug
Approval Package

Butalbital, Acetaminophen and Caffeine Tablets, Drug Approval Package

Butalbital, Acetaminophen and Caffeine Tablets, Drug Approval Package


September 25, 2002

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Sprintec-28 (Norgestimate & Ethinyl Estradiol) Tablets, Barr Laboratories,
Inc.

VIDEX (didanosine) Buffered Tablets, Buffered Powder for Oral Solution, &
Pediatric Powder, Bristol-Myers Squibb Company

Acyclovir Tablets, Drug Approval Package

Acyclovir Capsules, Drug Approval Package

Butorphanol Tartrate Injection USP, Drug Approval Package

Butorphanol Tartrate Injection USP, Drug Approval Package

Cimetidine Tablets USP, Drug Approval Package

Clonazepam USP Tablets, Drug Approval Package

Dipyridamole Single-Dose Vials, Drug Approval Package

Etoposide Injection USP, Drug Approval Package

Gemfibrozil Tablets USP, Drug Approval Package

Haloperidol Decanoate Injection, Drug Approval Package

Hydroxyurea Capsules USP, Drug Approval Package

Hydroxyurea Capsules USP, Drug Approval Package

Labetalol Hydrochloride Tablets USP, Drug Approval Package

Labetalol Hydrochloride Tablets USP, Drug Approval Package

Lorazepam Injection USP, Drug Approval Package

Metoprolol Tartrate Injection, Drug Approval Package

Pentoxifylline Extended-release Tablets, Drug Approval Package

Verapamil Hydrochloride Injection USP, Drug Approval Package


September 24, 2002

Guidance Agenda: Guidances CDER is Planning to Develop
http://www.fda.gov/cder/guidance/guidance-agenda.htm

Approved Active Moieties to which FDA has Issued a Written Request for
Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic
Act (posted 9/24/2002)
http://www.fda.gov/cder/pediatric/wrlist.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Aciphex (Rabeprazole Sodium) Delayed-Release Tablets, Eisai Inc.

Lupron PED (leuprolide acetate) Depot, TAP Pharmaceutical Products, Inc.

Chlorpromazine Hydrochloride Oral Concentrate USP, Pharmaceutical
Associates, Inc.Drug Approval Package

Dobutrex Solution (Dobutamine) Injection, Drug Approval Package

Imagent, Drug Approval Package

Sulfacetamide Sodium Ophthalmic Solution USP, Akorn, Inc.Drug Approval
Package

Pediatric Exclusivity Statistics as of August 31, 2002 (posted 9/24/2002)
http://www.fda.gov/cder/pediatric/wrstats.htm

Spectrum of Diseases/Conditions Written Requests as of August 31, 2002
(posted 9/24/2002)
http://www.fda.gov/cder/pediatric/specdis.htm


September 23, 2002

Calendar of Events: CDER Advisory Committee Meetings
http://www.fda.gov/cder/coe.htm

Guidance Documents: New/Revised/Withdrawn List (9/23/2002)
http://www.fda.gov/cder/guidance/New-Revised-Withdrawn.PDF

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Cancidas (caspofungin acetate) Injection, Merck Research Laboratories

HEPSERA (adefovir dipivoxil) Tablets, Gilead Sciences, Inc.

Mevacor (lovastatin) Tablets, Merck & Co., Inc.

Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca L.P.

Sustiva (Efavirenz) Tablets & Capsules, Bristol-Myers Squibb

ULTRAVIST (brand of iopromide) Injection, Berlex Laboratories, Inc.

Zoloft (sertraline hydrochloride) Tablets & Oral Concentrate, Pfizer
Pharmaceuticals


Drug Information (Updated 9/20/2002)

September 20, 2002

Establishing Pregnancy Exposure Registries [Word]
http://www.fda.gov/cder/guidance/3626fnl.doc
or [PDF]
http://www.fda.gov/cder/guidance/3626fnl.pdf

NDA Approvals for Calendar Year 2002
http://www.fda.gov/cder/rdmt/ndaaps02cy.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Crixivan (Indinavir Sulfate) Capsules, Merck & Co. Inc.

GoLYTELY (PEG-3350 and Electrolytes) for Oral Solution, Braintree
Laboratories, Inc.

INDIUM In 111 Oxyquinoline Solution, Amersham Health

Myleran (busulfan) Tablets, GlaxoSmithKline

Viagra (Sildenafil Citrate) Tablets, Pfizer, Inc.

Oxycodone and Acetaminophen Tablets, Drug Approval Package

Drug Shortages
http://www.fda.gov/cder/drug/shortages/default.htm

Products Experiencing Limited Distribution: Thiola (tiopronin) 100 mg
tablets
http://www.fda.gov/cder/drug/shortages/default.htm#Limited


September 19, 2002

CDER Organization Charts
Center for Drug Evaluation Research
Organizational Chart
http://www.fda.gov/cder/cderorg/cder.pdf

Office of Center Director
http://www.fda.gov/cder/cderorg/ocd.pdf

Office of Pharmaceutical Sciences
http://www.fda.gov/cder/cderorg/ops.pdf

Office of Pharmacoepidemiology and Statistical Science
http://www.fda.gov/cder/cderorg/OPSS.PDF

Office of New Drugs
http://www.fda.gov/cder/cderorg/OND.PDF

Warning Letters and Notice of Violation Letters to Pharmaceutical Companies

http://www.fda.gov/cder/warn/warn2002.htm


September 18, 2002

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Correction to Vinorelbine Listing: This is a Tentative Approval

Hydrochlorothiazide Capsules, Vintage Pharmaceuticals, Inc., posted 9/18/02

Zoloft (sertraline hydrochloride) Tablets & Oral Concentrate, Pfizer
Pharmaceuticals, posted 9/18/02

Carboplatin Injection USP, Bedford Laboratories, Tentative Approval, posted
9/18/02

Mirtazapine Tablets, Purepac Pharmaceutical Co., Tentative Approval, posted
9/18/02

Patent Term Extension and New Patents Docket Number *95S-0117
http://www.fda.gov/cder/orange/docket.pdf


September 17, 2002

Advisory Committee Rosters for Antiviral Drugs, Dermatologic and Ophthalmic
Drugs, and Pharmaceutical Science (updated)
http://www.fda.gov/cder/audiences/acspage/acslist1.htm

CDER Advisory Committee Staff (updated)
http://www.fda.gov/cder/audiences/acspage/acsPOClist1.htm

CDER Ombudsman Page Updated
http://www.fda.gov/cder/ombud.htm

FDA Consumer, September-October 2002
http://www.fda.gov/fdac/502_toc.html

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Amoxicillin & Clavulanate Potassium Tablets USP, Ranbaxy Laboratories Ltd.

Atacand (candesartan cilexetil), Tablets, AstraZeneca LP

Avapro (irbesartan) Tablets, Sanofi-Synthelabo, Inc.

Colyte (PEG and Electrolytes) Oral Solution, Schwarz Pharma, Inc.

Cozaar (losartan potassium) Tablets, Merck & Co., Inc.

Cysto-CONRAY & Cysto-CONRAY II (iothalamate meglumine 43% & 17.2%) Injection
USP, Mallinckrodt Inc.

Desmopressin Acetate Nasal Spray, Ferring Pharmaceuticals Inc.

Fosamax (alendronate sodium) Tablets, Merck & Co., Inc.

Sulfur Colloid Kit, CIS-US, Inc.

Vinorelbine Tartrate Injection, Gensia Sicor Pharmaceuticals, Inc.

Posicor (Mibefradil Dihydrochloride) Tablets, Drug Approval Package

New Molecular Entities (NMEs) Approved in Calendar Year 2002
http://www.fda.gov/cder/rdmt/NMECY2002.HTM

Studies Breakdown Report for Issued Written Requests: Pediatric Exclusivity
http://www.fda.gov/cder/pediatric/breakdown.htm


Drug Information (Updated 9/06/2002)

September 6, 2002

FDA announces the consolidation of FDA's responsibility for reviewing new
pharmaceutical products into its Center for Drug Evaluation and Research
(CDER). FDA Press Release.
http://www.fda.gov/bbs/topics/NEWS/2002/NEW00834.html

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Cefaclor Extended-release Tablets, USP, Teva Pharmaceuticals

Fenofibrate Capsules (Micronized), Novopharm Limited

Lescol Capsules & Lescol XL (fluvastatin sodium) Extended release Tablets,
Novartis Pharmaceutical Corporation

Monistat 1 Combination Pak, Personal Products

Nortrel 7/7/7 (Norethindrone and Ethinyl Estradiol) Tablets USP, Barr
Laboratories, Inc.

Paragraph IV Drug Patent Certifications
http://www.fda.gov/cder/ogd/ppiv.htm


September 5, 2002

Combination Products Program
http://www.fda.gov/oc/ombudsman/combination.html

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Aldara (imiquimod) Cream, 3M Pharmaceuticals

Aleve (naproxen sodium) Tablets, Capsules & Gelcaps, Bayer Consumer Care
Division

Arimidex (anastrozole) Tablets, AstraZeneca Pharmaceuticals

Cyclocort (amcinonide) Ointment, Fujisawa Healthcare, Inc.

Glycine Irrigation, Baxter Healthcare Corporation

Glycine Irrigation, Baxter Healthcare Corporation

Kenalog in Orabase (triamcinolone Acetonide Dental Paste, USP),
Bristol-Myers Squibb Company

Motrin Sinus/Headache (Ibuprofen & Pseudoephedrine HCI) Caplets, McNeil
Consumer and Specialty Pharmaceuticals

Prevacid (lansoprazole) SoluTab Orally Desintegrating Delayed-Release,
Capsules & Oral Suspension, TAP Pharmaceutical Products, Inc.

Rebetol (ribavirin) Capsules, Schering Corporation

Skelaxin (metaxalone) Tablets, Elan Pharmaceuticals, Inc.

Sorbitol Urologic Irrigation Solution, Baxter Healthcare Corp.

Vasotec (Enalapril Maleate) Tablets, Biovail Technologies Ltd.

Westcort (hydrocortisone valerate ointment) Ointment, Bristol-Myers Squibb
Pharmaceutical Research Institute


Office of Generic Drugs
Approvals (9/5/2002)
http://www.fda.gov/cder/ogd/approvals/AP0802.htm

First-Time Generics (9/5/2002)
http://www.fda.gov/cder/ogd/approvals/1stgen0802.htm

Tentative Approvals (9/5/2002)
http://www.fda.gov/cder/ogd/approvals/TA0802.htm


September 4, 2002

Patent Term Extension and New Patents Docket Number *95S-0117
http://www.fda.gov/cder/orange/docket.pdf

Warning Letters and Notice of Violation Letters to Pharmaceutical Companies
http://www.fda.gov/cder/warn/warn2002.htm


Drug Information (Updated 8/30/2002)

August 30, 2002

Advisory Committee Charter for Oncologic Drugs (updated)
http://www.fda.gov/cder/audiences/acspage/Oncologiccharter1.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Celebrex (Celecoxib) Capsules, Pharmacia Corporation

Celebrex (Celecoxib) Capsules, Pharmacia Corporation

Copaxone (glatiramer acetate) Injection, TEVA Pharmaceuticals USA

Fluoxetine Oral Solution USP, Morton Grove Pharmaceuticals, Inc.

Lexapro (escitalopram oxalate) Tablets, Forest Laboratories, Inc.

Loperamide Hydrochloride & Simethicone Chewable Tablets, L. Perrigo Company

Monopril (fosinopril soidum) Tablets, Bristol-Myers Squibb Company

Penicillin G Potassium Injection, USP, Biochemie GmbH

Permax (pergolide mesylate) Tablets, Eli Lilly and Company

Ranitidine Tablets, L. Perrigo Co.

Rimantadine Hydrochloride Tablets, Impax Laboratories

Taxol (paclitaxel) Injection, Bristol-Myers Squibb

Tizanidine Capsules, Elan Pharmaceuticals

Tamoxifen Citrate Tablets USP, IVAX Pharmaceuticals, Tentative Approval


August 29, 2002

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Celebrex (celecoxib) Capsules, Drug Approval Package

NovoLog Mix 70/30 Injection, Drug Approval Package


August 28, 2002

Drug Labeling Updates-July
http://www.fda.gov/cder/ogd/rld/rld_labeling_approved_july_2002.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Megace (megestrol acetate) Tablets, Bristol Myers Squibb Co.

News Along the Pike August 2002 HTML
http://www.fda.gov/cder/pike/august2002.htm
or PDF
http://www.fda.gov/cder/pike/August2002.pdf


August 27, 2002

Cyber Warning Letters to Companies Selling Products on the Internet
http://www.fda.gov/cder/warn/cyber/cyber2002.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Anturane (sulfinpyrazone USP), Novartis Pharmaceuticals Corporation

Fiorinal with Codeine (butalbital, aspirin, caffeine, and codeine phosphate)
Capsules, Novartis Pharmaceuticals Corporation

Naproxen Sodium Extended-release Tablets, Andrx Pharmaceuticals, Inc.

You have a hand in your health with the safe and effective use of medicines
http://www.fda.gov/cder/consumerinfo/haveAhand.htm


August 26, 2002

Calendar of Events: CDER Advisory Committee Meetings
http://www.fda.gov/cder/coe.htm

Draft Guidance for Industry and Clinical Investigators: The Use of Clinical
Holds Following Clinical Investigator Misconduct
http://www.fda.gov/OHRMS/DOCKETS/98fr/02d-0320-gdl0001.pdf

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

DUAC (clindamycin, 1% - benzoyl peroxide, 5%) Topical Gel, Stiefel
Laboratories, Inc.

Lumigan (bimatoprost ophthalmic solution), Allergan, Inc.

Proloprim (trimethoprim) Tablets, Monarch Pharmaceuticals, Inc.

Xalatan (latanoprost) ophthalmic solution, Pharmacia & Upjohn Company


Drug Information (Updated 8/16/2002)

August 16, 2002

FDA co-sponsored Special Dosage Workshop September 16-18, 2002, Crystal
Gateway Marriott, Arlington, VA. http://www.aapspharmaceutica.com/dosage/

FDA co-sponsored Biopharmaceutics Classification System Workshop. September
25-27, 2002, Crystal Gateway Marriott, Arlington, VA.
http://www.aapspharmaceutica.com/biosys/

The FY 2003 Product and Establishment invoices were mailed on Thursday,
August 15, 2002. They are due October 1, 2002
http://www.fda.gov/cder/pdufa/default.htm

Patent Term Extension and New Patents Docket Number *95S-0117
http://www.fda.gov/cder/orange/docket.pdf


August 14

A Review of Procedures for the Detection of Residual Penicillins in Drugs
http://www.fda.gov/cder/dmpq/penicillin.pdf

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Actigall (ursodiol) Capsules, Novartis Pharmaceuticals Corporation
Bentyl (dicyclomine hydrocholride) Injection, Aventis Pharmaceuticals
Diovan (valsartan) Capsules & Tablets, Novartis Pharmaceuticals Corporation
Fosamax (alendronate sodium) Tablets, Merck & Co., Inc.
HIVID (zalcitabine) Tablets, Hoffman-La Roche, Inc.
NicoDerm CQ, GlaxoSmithKline Consumer Healthcare
Trizivir (abacavir sulfate, lamivudine, zidovudine) Tablets, GlaxoSmithKline

Ziagen (abacavir sulfate) Tablets and Oral Solution, GlaxoSmithKline
Cardioquin (Quinidine Polygalacturonate) Tablets, Drug Approval Package
Septocaine (articaine & epinephrine) Injection, Drug Approval Package
TechneScan MDP Kit, Drug Approval Package
http://www.fda.gov/cder/foi/nda/index96.htm
Verelan PM (verapamil hydrochloride) Capsules, Drug Approval Package


August 13, 2002

FDA releases Statement on the Results of the Women's Health Initiative
http://www.fda.gov/cder/drug/safety/WHI_statement.htm


August 12, 2002

Advisory Committee Meeting Rosters (updated)
http://www.fda.gov/cder/audiences/acspage/acslist1.htm

Calendar of Events: CDER Advisory Committee Meetings
http://www.fda.gov/cder/coe.htm

Eloxatin (oxaliplatin) Information Page
http://www.fda.gov/cder/drug/infopage/eloxatin/default.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Meperidine Hydrochloride Tablets USP, Caraco Pharmaceutical Laboratories
Ltd.
Milrinone Lactate Injection, ESi Lederle
Carboplatin Injection USP, Gensia Sicor Pharmaceuticals, Inc., Tentative
Approval

Patent Term Extension and New Patents Docket Number *95S-0117 (8/12/2002)
http://www.fda.gov/cder/orange/docket.pdf

Tentative Advisory Committee Meetings, CDER
http://www.fda.gov/cder/meeting/advisorycomyear.htm


Drug Information (Updated 8/09/2002)

August 9, 2002

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Androderm (testosterone transdermal system), Watson Laboratories, Inc.
BenzaClin Topical Gel, Dermik Laboratories
Combivir (lamivudine/zidovudine) Tablets, GlaxoSmithKline
DDAVP (desmopressin acetate) Injection, Aventis Pharmaceutical Products
Diflucan (Fluconazole) Tablets, Injection & Oral Powder, Pfizer, Inc.
Entocort EC (Budesonide) Capsules, AstraZeneca LP
Nicorette (Nicotine Polacrilex) Gum, SmithKline Beecham Consumer Healthcare

Office of Generic Drugs
Approvals http://www.fda.gov/cder/ogd/approvals/AP0702.htm

First-Time Generics http://www.fda.gov/cder/ogd/approvals/1stgen0702.htm

Tentative Approvals http://www.fda.gov/cder/ogd/approvals/TA0702.htm

Paragraph IV Drug Patent Certifications http://www.fda.gov/cder/ogd/ppiv.htm

Think It Through: A Guide to Managing the Benefits and Risks of Medicines
http://www.fda.gov/cder/consumerinfo/think.htm


August 8, 2002

Advisory Committee Meeting Information
http://www.fda.gov/cder/audiences/acspage/acslist1.htm

Certificate of Pharmaceutical Product
http://www.fda.gov/cder/guidance/pharmCert2002.pdf

Treatment IND List Allowed to Proceed
http://www.fda.gov/cder/foi/special/TrtINDlst.pdf

Labeling Review Branch Page Updated
http://www.fda.gov/cder/ogd/rld/LABELING_REVIEW_BRANCH.HTML

June Reference Listed Drug Products Updated
http://www.fda.gov/cder/ogd/rld/rld_labeling_approved_june_2002.htm

New Drug Approval Reports http://www.fda.gov/cder/rdmt/default.htm

Efficacy Supplements Approved in Calendar Year 2002
http://www.fda.gov/cder/rdmt/ESCY02AP.HTM

NDA Approvals for Calendar Year 2002
http://www.fda.gov/cder/rdmt/ndaaps02cy.htm

NDAs Approved under Subpart H http://www.fda.gov/cder/rdmt/accapp.htm

NDA Supplements Approved under Subpart H
http://www.fda.gov/cder/rdmt/accappr1.htm

New Molecular Entities (NMEs) Approved in Calendar Year 2002
http://www.fda.gov/cder/rdmt/NMECY2002.HTM

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Caverject (Alprostadil) Injection, Drug Approval Package
Celexa (citalopram Hbr), Drug Approval Package
Cromolyn Sodium Nasal Solution, Drug Approval Package
Tavist Allergy/Sinus/Headache (0.335mg clemastine fumarate, 30mg
pseudoephedrine hydrochloride, 500mg acetaminophen), Drug Approval Package

GENERIC DRUG APPROVAL PACKAGES http://www.fda.gov/cder/foi/anda/index97.htm

Acetic Otic Solution USP, Drug Approval Package
Adriamycin PFS (Doxorubicin Hydrochloride) Injection, Drug Approval Package
Cefaclor Capsules USP, Drug Approval Package
Danazol Capsules USP, Drug Approval Package
Diflunisal Tablets USP, Drug Approval Package
Hydrocortisone & Acetic Acid Otic Solution USP
Nystatin Oral Suspension USP, Drug Approval Package
Promethazine Hydrochloride & Dextromethorphan Hydrobromide Syrup, Drug
Approval Package
Sterile Bleomycin Sulfate USP, Drug Approval Package
Sulster (Sulfacetamide Sodium, Drug Approval Package

August 7, 2002

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Monistat 7 Cream Combination Pak, Personal Products
Monistat 3 Vaginal Cream (Miconazole Nitrate), Personal Products
Alora (estradiol transdermal system), Drug Approval Package


August 6, 2002

FDA Drug Approvals List http://www.fda.gov/cder/da/da.htm

Potassium Chloride Modified-Release Tablets and Capsules: In Vivo
Bioequivalence and In Vitro Dissolution Testing [PDF] (Issued 8/2002, Posted
8/6/2002) http://www.fda.gov/cder/guidance/4955dft.pdf


August 5, 2002

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Acetaminophen and Codeine Tablets, Able Laboratories, Inc.
Agenerase (amprenavir) Capsules and Oral Solution, GlaxoSmithKline
Altace (ramipril) Capsules, King Pharmaceuticals, Inc.
Cinobac (cinoxacin) Capsules, Eli Lilly and Company
Clotrimazole & Betamethasone Dipropionate Cream USP, Alpharma
Darvon Compound 65 (propoxyphene hydrochloride, aspirin and caffeine)
Capsule, Darvon (propoxyphene hydrochloride) Capsules, Darvon N
(propoxyphene napsylate) Tablets, Lilly Reasearch Laboratories
Eskalith (lithium carbonate) Capsules and Eskalith CR (lithium carbonate)
Controlled Release Tablets, SmithKline Beecham Corporation
Famotidine Injection, Apotex Corp.
Fosamax (alendronate sodium) Tablets, Merck & Co., Inc.
Halfan (halofantrine hydrochloride) Tablets, GlaxoSmithKline
Malarone (atovaquone and proguanil hydrochloride) Tablets, GlaxoSmithKline
Milrinone Lactate Injection, International Medication Systems, Ltd.
Paclitaxel Injection, NaPro Biotherapeutics, Inc.
Pentazocine Hydrochloride & Acetaminophen Tablets, Amide Pharmaceuticals
Prevacid (lansoprazole) Delayed-Release Capsules, TAP Pharmaceutical
Products, Inc.

Patent Term Extension and New Patents Docket Number *95S-0117
http://www.fda.gov/cder/orange/docket.pdf


Drug Information (Updated 7/19/2002)

July 19, 2002

CDER's Experience: What We Have Learned from The Pediatric Initiative --
William Rodriguez, M.D.
http://www.fda.gov/cder/pediatric/presentation/ped_init_rodriguez/index.htm

Drug Shortages http://www.fda.gov/cder/drug/shortages/default.htm

Resolved Drug Shortage: MVI Pediatric
http://www.fda.gov/cder/drug/shortages/default.htm#Resolved

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Cordran (flurandrenolide) SP Cream, Watson Laboratories, Inc.
ELOCON (mometasone furoate) Cream, Schering Corporation
ELOCON (mometasone furoate) Lotion, Schering Corporation
ELOCON (mometasone furoate) Ointment, Schering Corporation
Factrel (gonadorelin HCl), Wyeth Pharmaceuticals
Glycine Irrigation, Baxter Healthcare Corporation
Irrigating Solution G (PL 325), Baxter Healthcare Corporation
Levoxyl (levothyroxine sodium) Tablets, Jones Pharma Inc.
Mandol (cefamandole nafate) Vials, Eli Lilly and Company
Nasonex (Mometasone Furoate) Nasal Spray, Schering Corp.
Sporanox (itraconazole) Oral Solution, Janssen Research Foundation
Sporanox (itraconazole) Injection, Johnson and Johnson Pharmaceutical
Research and Development. L.L.C.
Zyloprim (allopurinol) Tablets, Prometheus Laboratories
Patent Term Extension and New Patents Docket Number *95S-0117
http://www.fda.gov/cder/orange/docket.pdf


July 18, 2002

Warning Letters and Notice of Violation Letters to Pharmaceutical Companies
http://www.fda.gov/cder/warn/warn2002.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Xyrem (sodium oxybate) oral solution, Rx Orphan Medical, posted 7/18/02


July 17, 2002

FDA approves Xyrem under a restricted distribution plan for the treatment of
cataplexy associated with narcolepsy. Information Page with "Questions and
Answers" and "Medication Guide."
http://www.fda.gov/cder/drug/infopage/xyrem/default.htm


July 16, 2002

FDA and Elan Pharmaceuticals added a bolded Warning to the label of Zonegran
(zonisamide) to inform healthcare professionals that pediatric patients
appear to be at an increased risk for zonisamide-associated oligohidrosis
and hyperthermia. MedWatch Safety Information.
http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#zonegr

FDA Drug Approvals List http://www.fda.gov/cder/da/da.htm


New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Habitrol (nicotine transdermal system), Novartis Consumer Health, Inc.
Prilosec (omeprazole) Delayed-Release Capsules, AstraZeneca LP

PDFUFA Page updated The Product and Establishment invoices for FY 2002
Cleanup I (covering new product approvals through May and new manufacturing
sites) were mailed on Tuesday, July 16, 2002. They are due August 16, 2002
http://www.fda.gov/cder/pdufa/default.htm


July 15, 2002

Analgesia and Anti-inflammatory Drug Information
http://www.fda.gov/cder/drug/Analgesia_antiinflam/default.htm

Bioavailability and Bioequivalence Studies for Orally Administered Drug
Products - General Considerations [HTML]
http://www.fda.gov/cder/guidance/4964dft.htm or [PDF]
http://www.fda.gov/cder/guidance/4964dft.pdf

CDER Organization Charts
Center for Drug Evaluation Research Organizational Chart
http://www.fda.gov/cder/cderorg/cder.pdf

Office of Center Director http://www.fda.gov/cder/cderorg/ocd.pdf

Office of Pharmaceutical Sciences http://www.fda.gov/cder/cderorg/ops.pdf

Office of Pharmacoepidemiology and Statistical Science
http://www.fda.gov/cder/cderorg/OPSS.PDF

Office of New Drugs http://www.fda.gov/cder/cderorg/OND.PDF

Electronic Submissions of Abbreviated New Drug Applications (ANDAs)
(updated) http://www.fda.gov/cder/regulatory/ersr/default.htm#anda

FDA Consumer, July-August 2002 http://www.fda.gov/fdac/402_toc.html

June 2002 Annual Drug Information Association Meeting Presentations
(updated) http://www.fda.gov/cder/present/DIA62002/default.htm

NDA Approvals for Calendar Year 2001
http://www.fda.gov/cder/rdmt/ndaaps01cy.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Actos (pioglitazone) Tablets, Takeda
Cleocin T (clindamycin phosphate) Topical Solution, Gel, and Topical Lotion,
Pharmacia
Habitrol (nicotine transdermal system), Novartis Consumer Health, Inc.
Mucinex (Guaifenesin) Extended-Release Tablets, Adams Laboratories, Inc.
Prednisone Tablets USP, Vintage Pharmaceuticals, Inc.
Renova (tretionin) Cream, Johnson and Johnson Consumer Industries, Inc.
Tramadol Hydrochloride Tablets, Asta Medica, Inc.
Tamoxifen Citrate Tablets USP, Andrx Pharmaceuticals, Inc., Tentative
Approval


Drug Information (Updated 7/12/2002)

July 12, 2002

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Aredia (pamidronate disodium) Injection, Novartis Pharmaceuticals
Corporation
GlucaGen [glucagon (rDNA origin) for Injection, Novo Nordisk Pharmaceuticals

Pravachol (Pravastatin Sodium) Tablets, Bristol-Myers Squibb
Tizanidine Hydrochloride Tablets, Purepac Pharmaceutical
Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets,
GlaxoSmithKline

Office of Generic Drugs
Approvals http://www.fda.gov/cder/ogd/approvals/AP0602.htm

First-Time Generics http://www.fda.gov/cder/ogd/approvals/1stgen0602.htm

Tentative Approvals http://www.fda.gov/cder/ogd/approvals/TA0602.htm

Generic Drug Petition Tracking http://www.fda.gov/cder/ogd/suitabil.htm

Tentative Advisory Committee Meetings, CDER
http://www.fda.gov/cder/meeting/advisorycomyear.htm


July 11, 2002

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Altace (ramipril) Capsules, King Pharmaceuticals, Inc.
Loniten (minoxidil) Tablets, Pharmacia & Upjohn Company
Misoprostol Tablets, IVAX Pharmaceuticals, Inc.
Procanbid (procainamide hydrochloride) extended-release tablets, King
Pharmaceuticals, Inc.
Tramadol Hydrochloride Tablets, TorPharm
Amiodarone Hydrochloride Injection, Bionice Pharma Ltd., Tentative Approval
Mometasone Furoate Ointment USP, Altana Inc., Tentative Approval
Mometasone Furoate Ointment USP, Altana Inc., Tentative Approval
Drug Information Association, 38th Annual Meeting, Chicago, Illinois, June
16-20, 2002: Presentations.
http://www.fda.gov/cder/present/DIA62002/default.htm


July 10, 2002

Investigational Human Drugs: Clinical Investigator Inspection List
http://www.fda.gov/cder/regulatory/investigators/default.htm


July 9, 2002

Drug Labeling Updates
http://www.fda.gov/cder/ogd/rld/labeling_review_branch.html

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Cortifoam (hydrocortisone acetate rectal metered aerosol), Schwartz Pharma,
Inc.
Edetate Disodium Injection USP, Bioniche Pharma Ltd.
M.V.I. Pediatric (Multi-Vitamins for Infusion), NeoSan Pharmaceuticals
Nizatidine Capsules USP, Genpharm Inc.
Nizatidine Capsules USP, Watson Laboratories, Inc.
Nizatidine Capsules USP, Zenith Goldline Pharmaceuticals, Inc.
Taxotere (docetaxel) Injection Concentrate, Aventis Pharmaceutical Products
Inc.
Loratadine and Pseudoephedrine Sulfate Extended-release Tablets, Andrx
Pharmaceuticals, L.L.C., Tentative Approval

Pediatric Initiatives: a Regulatory Perspective of the U.S. Experience --
June 17, 2002, Debra Birenbaum, M.D.
http://www.fda.gov/cder/pediatric/presentation/Ped_Init_2002_DB/index.htm


July 8, 2002

Calendar of Events http://www.fda.gov/cder/coe.htm

FDA Drug Approvals List http://www.fda.gov/cder/da/da.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Ciprofloxacin Tablets USP, Dr. Reddy's Laboratories Ltd.
Clozaril (clozapine) Tablets, Novartis Pharmaceuticals Corporation
DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension,
Bristol-Myers Squibb Medical Imaging, Inc.
HIVID (zalcitabine) Tablets, Hoffman-La Roche, Inc.
Isovue-M (iopamidol injection), Bracca Diagnostics Inc.
Lisinopril & Hydrochlorothiazide Tablets USP, West-ward Pharmaceutical Corp.

OMNISCAN (gadodiamide) Injection, Nycomed Amersham Imaging
TESLASCAN (mangafodipir trisodium) Injection, Nycomed Amersham Imaging


Drug Information (Updated 7/05/2002)

July 5, 2002

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Labetalol Hydrochloride Injection USP, Apotex Corp.
MDP Kit (Technetium Tc99m Medronate) Injection, Draximage Inc.
Nizatidine Capsules USP, Mylan Pharmaceuticals, Inc.
Nizatidine Capsules USP, Eon Labs Manufacturing, Inc.
Oxaprozin Tablets, Teva Pharmaceuticals
Sevoflurane Inhalation, Baxter Healthcare Corporation
Sorbitol Irrigation Solution, Baxter Healthcare Corp.
Tizanidine Hydrochloride Tablets, Teva Pharmaceuticals
Tizanidine Hydrochloride Tablets, Dr. Reddy's Laboratories Ltd

DRUG APPROVAL PACKAGES

Benicar (olmesartan medoxomil) Tablets, Drug Approval Package , posted
7/5/02
DepoCyt (Cytarabine Liposomal Injection), Drug Approval Package , posted
7/5/02
Vasotec I.V. (Enalapril), (Enalapril Maleate) Tablets, & (Enalapril
Maleate/Hydrochlorothiazide) Tablets, Drug Approval Package , posted 7/5/02
Zocor (simvastatin) Tablets, Drug Approval Package , posted 7/5/02
Zometa (zoledronic acid for injection), ,Drug Approval Package , posted
7/5/02

July 3, 2002

Approved Drug Products with Therapeutic Equivalence Evaluations-22nd Edition
(Cumulative Supplement-5)
http://www.fda.gov/cder/orange/supplement/cspreface.htm
[Information and Data Files] http://www.fda.gov/cder/orange/obreadme.htm

Approved Drug Products with Therapeutic Equivalence: Query
http://www.fda.gov/cder/ob/default.htm

Approved Drug Products with Therapeutic Equivalence Evaluations Monthly
Additions and Deletions (May)
http://www.fda.gov/cder/rxotcdpl/pdpl_200205.htm

Calendar of Events: CDER Advisory Committee Meetings
http://www.fda.gov/cder/coe.htm

Nasal Spray and Inhalation Solution, Suspension, and Drug Products [HTML]
http://www.fda.gov/cder/guidance/4234fnl.htm
or [PDF]
http://www.fda.gov/cder/guidance/4234fnl.pdf

National Drug Code (NDC) Directory http://www.fda.gov/cder/ndc/index.htm

National Drug Code Search http://www.fda.gov/cder/ndc/database/default.htm

Paragraph IV Drug Patent Certifications http://www.fda.gov/cder/ogd/ppiv.htm

July 2, 2002

The Boxed Warning, Warnings, and Precautions sections of Camptosar
(irinotecan hydrochloride) label have been revised to identify patients at
higher risk of severe toxicity, to clarify dose modification guidelines, and
to augment information about management of treatment-related toxicities,
including severe and occasionally life-threatening diarrhea. MedWatch
Safety Information.
http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#campto

FDA issues a response to a Citizen's Petition submitted to the agency
regarding the regulation of a product called "Nicotine Water." FDA has
determined that this product should be regarded as an unapproved new drug
and cannot be legally marketed as a dietary supplement. FDA News.
http://www.fda.gov/bbs/topics/NEWS/2002/NEW00818.html


New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Fortovase (saquinavir) Soft Gelatin Capsules, Hoffman-La Roche, Inc.
Lisinopril & Hydrochlorothiazide Tablets USP, Purepac Pharmaceutical Co.
Prinzide (Lisinopril/Hydrochlorothiazide) Tablets, Merck & Co., Inc.
Tramadol Hydrochloride Tablets, Sidmak Laboratories, Inc.


July 1, 2002

FDA Drug Approvals List http://www.fda.gov/cder/da/da.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Lisinopril Tablets USP, Eon Labs Inc.
Lisinopril Tablets USP, Geneva Pharmaceutical Technology Corp.
Lisinopril Tablets USP, Ivax Pharmaceuticals, Inc
Lisinopril Tablets USP, Lek Pharmaceutical and Chemical Company
Lisinopril Tablets USP, Mylan Pharmaceuticals, Inc.
Lisinopril Tablets USP, Par Pharmaceuticals, Inc.
Lisinopril Tablets USP, Purepac Pharmaceutical Co.
Lisinopril Tablets USP, Purepac Pharmaceutical Co.
Lisinopril Tablets USP, Ranbaxy Laboratories Limited
Lisinopril Tablets USP, TEVA Pharmaceuticals USA
Lisinopril Tablets USP, Watson Laboratories, Inc.
Lisinopril Tablets USP, West-ward Pharmaceutical Corp.
Lisinopril & Hydrochlorothiazide Tablets USP, Eon Labs, Inc.
Lisinopril & Hydrochlorothiazide Tablets USP, Geneva Pharmaceutical
Technology Corporation
Lisinopril & Hydrochlorothiazide Tablets, Ivax Pharmaceuticals Inc.
Lisinopril & Hydrochlorothiazide Tablets USP, Mylan Pharmaceuticals, Inc.
Lisinopril & Hydrochorothiazide Tablets USP, Ranbaxy Pharmaceuticals Inc.
Lisinopril & Hydrochlorothiazide Tablets USP, TEVA Pharmaceuticals USA
Lisinopril & Hydrochlorothiazide Tablets USP, Watson Laboratories, Inc.
Omniscan, Amersham Health
Parafon (chlorzoxazone) Forte DSC, McNeil Consumer Products Company
Prednisolone Sodium Phosphate Oral Solution, Morton Grove Pharmaceuticals,
Inc.


Drug Information (Updated 6/13/2002)

June 13, 2002

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Avelox (moxifloxacin) Tablets and Avelox (moxifloxacin) Injection, Bayer
Corporation
Midazolam Hydrochloride Injection, Abbott Laboratories
Neoral (cyclosporine) Soft Gelatin Capsules USP, Novartis Pharmaceuticals
Corporation
NephrAmine (essential amino acid injection), B. Braun Medical Inc.
M2 Electronic Common Technical Document Specification [HTML]
http://www.fda.gov/cder/guidance/5017dft.htm or [PDF]
http://www.fda.gov/cder/guidance/5017dft.pdf
Q1E Evaluation of Stability Data [HTML]
http://www.fda.gov/cder/guidance/4983dft.htm or [PDF]
http://www.fda.gov/cder/guidance/4983dft.pdf
Q1F Stability Data Package for Registration in Climatic Zones III and IV
[HTML] http://www.fda.gov/cder/guidance/4984dft.htm or [PDF]
http://www.fda.gov/cder/guidance/4984dft.pdf
S7B Safety Pharmacology Studies for Assessing the Potential for Delayed
Ventricular Repolarization (QT Interval Prolongation) by Human
Pharmaceuticals [HTML] http://www.fda.gov/cder/guidance/4970dft.htm or
[PDF] http://www.fda.gov/cder/guidance/4970dft.PDF

June 12, 2002

Drug Shortages http://www.fda.gov/cder/drug/shortages/default.htm
Products Experiencing Limited Distribution: Gastrocrom (cromolyn sodium,
USP) Oral Concentrate 6/12/2002
http://www.fda.gov/cder/drug/shortages/default.htm#Limited
FDA Drug Approvals List http://www.fda.gov/cder/da/da.htm
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Actiq (oral transmucosal fentanyl citrate), Cephalon, Inc.
Ammonium Lactate Lotion, Paddock Laboratories, Inc.
Aphthasol (Amlexanox) Oral Paste, GlaxoSmithKline Consumer Healthcare
Caverject (Alprostadil) Injection, Pharmacia & Upjohn
Humatrope [Somatropin, (rDNA origin) for injection], Eli Lilly & Co.
Lithium Carbonate Extended-Release Tablets USP, Barr Laboratories, Inc.
Retin-A (tretinoin) Liquid, Cream, 0.1%, Cream, 0.05%, Gel, 0.025%, Gel,
0.01%, and Cream, 0.025%., Johnson & Johnson Consumer Companies, Inc.
Salagen (pilocarpine HCL) Tablets, MGI Pharma, Inc.
Sarafem (fluoxetine hydrochloride) Capsules
Tretinoin Gel USP, Spear Pharmaceuticals, Inc.

June 11, 2002

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Ferrlecit (sodium ferric gluconate complex in sucrose injection), R&D
Laboratories
Levothyroxine Sodium Tablets USP, Mylan Pharmaceuticals Inc.

June 10, 2002

Tentative Advisory Committee Meetings, CDER
http://www.fda.gov/cder/meeting/advisorycomyear.htm


Drug Information (Updated 5/28/2002)

May 28, 2002

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Biaxin Filmtab and Biaxin® Granules, Abbott Laboratories
Diphenhydramine Hydrochloride Injection USP, American Pharmaceutical
Partners, Inc.
Ifosfamide Injection, American Pharmaceutical Partners, Inc.
Milrinone Lactate Injection, Baxter Healthcare Corporation
Milrinone Lactate Injection, Faulding Pharmaceutical Company
Milrinone Lactate Injection, Abbott Laboratories
Milrinone Lactate Injection, Abbott Laboratories
Milrinone Lactate Injection, Baxter Healthcare Corporation
Milrinone Lactate Injection, ESI Lederle
Milrinone Lactate Injection, American Pharmaceutical Partners, Inc.
Milrinone Lactate in 5% Dextrose Injection, ESI Lederle
Neurontin (gabapentin) tablets, capsules and oral solution, Parke-Davis
Pharmaceutical Research
Norvasc (amlodipine besylate) Tablets, Pfizer Inc.
Vancocin HCl (vancomycin hydrochloride capsules, USP) Pulvules, Eli Lilly
and Company
VFEND (voriconazole) Tablets & VFEND (voriconazole for infusion), Pfizer
Inc.
Zithromax TRI-PAK (azithromycin) Tablets, Pfizer Inc.
Zithromax (azithromycin) Pediatric Oral Suspension, and Zithromax
(azithromycin)Tablets,Pfizer Inc.
Loratadine and Pseudoephedrine Sulfate Extended-release Tablets, Impax
Laboratories, Inc., Tentative Approval
Schering-Plough - FDA Complaint for Injunction [HTML]
http://www.fda.gov/cder/dmpq/SPcomplaint.htm or [PDF]
http://www.fda.gov/cder/dmpq/spcomplaint.pdf


Drug Information (Updated 5/10/2002)

May 10, 2002

FDA posts letter from GlaxoSmithKline Alerting Patients, Pharmacists and
Physicians to Watch for Third-Party Tampering that Incorrectly Labels Ziagen
as Combivir MedWatch Safety Information. (5/10/2002)
http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#comb

Container Closure Systems for Packaging Human Drugs and Biologics --
Questions and Answers [PDF] http://www.fda.gov/cder/guidance/4828fnl.PDF

Direct-to-Consumer Advertising of Prescription Drugs: Preliminary Patient
Survey Results http://www.fda.gov/cder/ddmac/DTCnational2002a/sld001.htm

Drug Registration and Listing (Updated)
http://www.fda.gov/cder/drls/registration_listing.htm

Electronic IND Submissions (Updated)
http://www.fda.gov/cder/regulatory/ersr/default.htm#INDs)

FDA Consumer magazine, May-June 2002 issue
http://www.fda.gov/fdac/302_toc.html

New Molecular Entities (NMEs) Approved in Calendar Year 2002
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Buspirone Hydrochloride Tablets USP, PharmEx Products, Inc.
Etrafon (perphenazine & amitriptyline hydrochloride) Tablets, Schering
Corporation
Imitrex (sumatriptan succinate) Injection, Glaxo Wellcome
Optison (Human Albumin Microspheres) Injectable Suspension Octofluoropropane
Formulation, Mallinckrodt Inc.
Trilafon (perphenazine) tablets and injection, Schering Corporation

May 9, 2002

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Bravelle (Urofollitropin) Injection Purified, Ferring Pharmaceuticals, Inc.
Cyclosporine Capsules USP, TorPharm Inc.
Flonase (fluticasone propionate) Nasal Spray, GlaxoSmithKline, Inc.
Gemzar (gemcitabine HCl) for Injection, Eli Lilly
Librium (chlordiazepoxide hydrochloride) Injection, ICN Pharmaceuticals,
Inc.
Lithium Carbonate Capsules & Controlled Release Tablets, SmithKline Beecham
Corporation
Metformin Hydrochloride Extended-Release Tablets, Geneva Pharmaceuticals
Technology Corp.
Nasalide (Flunisolide) Nasal Spray, Ivax Research, Inc.
Paclitaxel Injection, Abbott Laboratories
Pamidronate Disodium Injection, Aesgen, Inc.
Qvar Inhalation Aerosol (beclomethasone dipropionate HFA), 3M
Pharmaceuticals
Amiodarone Hydrochloride Injection, Bedford Laboratories, Tentative Approval

Itraconazole Capsules, Eon Labs Manufacturing, Inc., Tentatively Approved

Roster of the Dermatologic and Ophthalmic Drugs Advisory Committee (Updated)

http://www.fda.gov/cder/audiences/acspage/dermatoogyroster1.htm


May 8, 2002

3M notifies healthcare professionals of a voluntary recall of Maxair Inhaler
(pirbulerof acetate inhalation aerosol), press and breathe metered dose
inhalers. MedWatch Safety Information
<http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm>.

Medication Errors: Reports and Articles
<http://www.fda.gov/cder/drug/MedErrors/reports.htm>

Name Differentiation Project
<http://www.fda.gov/cder/drug/MedErrors/nameDiff.htm>

May 7, 2002

Accutane Medication Guide. (Updated)
http://www.fda.gov/cder/drug/infopage/accutane/medicationguide.htm

Drug Shortage: Drug Experiencing Limited Distribution: Heparin Sodium
Injection, USP (Porcine Derived) 1000u/ml, 1 ml, 10 ml, and 30 ml vials.
5/7/2002
http://www.fda.gov/cder/drug/shortages/default.htm#Limited

FDA posts letters notifying healthcare professionals of product tampering
with Zyprexa, indicated for the treatment of schizophrenia and acute bipolar
mania. MedWatch Safety Information.
http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#zyprex

FDA posts new approved labeling for Vioxx (rofecoxib) to strengthen the
Warnings, Precautions, and Clinical Studies label sections describing new
cardiovascular and gastroenterological safety information. MedWatch Safety
Information. http://www.fda.gov/medwatch/safety/2002/safety02.htm#vioxx

Office of Generic Drugs
Approvals http://www.fda.gov/cder/ogd/approvals/AP0402.htm
First-Time Generics http://www.fda.gov/cder/ogd/approvals/1stgen0402.htm
Tentative Approvals http://www.fda.gov/cder/ogd/approvals/TA0402.htm
Paragraph IV Drug Patent Certifications http://www.fda.gov/cder/ogd/ppiv.htm

May 6, 2002

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Coumadin Tablets (Warfarin Sodium Tablets, USP) and Coumadin for Injection
(Warfarin Sodium), Bristol-Myers Squibb Pharma Company
Coumadin Tablets (Warfarin Sodium Tablets, USP) and Coumadin for Injection
(Warfarin Sodium), Bristol-Myers Squibb Pharma Company
Duricef (cefadroxil monohydrate, USP) Capsules, Oral Suspension & Tablets,
Bristol-Myers Squibb Company
NovoLog Mix 70/30 Injection, Novo Nordisk
Prevacid (lansoprazole) Delayed-Release Oral Suspension, TAP Pharmaceutical
Products, Inc.
Vivelle-Dot (estradiol transdermal system), Novartis Pharmaceuticals
Corporation
Zocor (simvastatin) Tablets, Merck & Co., Inc.
Metformin Hydrochloride Extended-Release Tablets, Geneva Pharmaceuticals
Technology Corp., Tentatively Approved


Drug Information (Updated 4/26/2002)

Drug Master Files http://www.fda.gov/cder/dmf/index.htm
FDA approves changes to strengthen the labeling for Actos and Avandia. The
Warnings, Precautions, and Adverse Reactions sections have been modified to
more clearly describe the cardiovascular risks associated with the use of
thiazolidinediones as monotherapy and in combination with other antidiabetic
agents, particularly insulin. MedWatch Safety Information.
http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#Thiazo
FDA approves Faslodex (fulvestrant) Injection for the treatment of hormone
receptor positive metastatic breast cancer in postmenopausal women with
disease progression following antiestrogen therapy. Faslodex Label
http://www.fda.gov/cder/foi/label/2002/21344lbl.pdf
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Benicar (olmesartan medoxomil) Tablets, Sankyo Pharma, Inc.
BUSULFEX (busulfan) Injection, Orphan Medical, Inc.
Chromic Chloride Injection, USP, Abbott Laboratories
Cosopt (Dorzolamide/Timolol Solution), Merck
E. E. S. Granules, EryPed® Drops, Ery Ped ® 200 and EryPed® 400
(erythromycin ethylsuccinate) oral suspension, USP, EryPed ® (erytrhomycin
ethylsuccinate) Chewable Tablets & PCE (erythormycin particles in tablets)
TabletsAbbott Laboratories
Guanidine HCl Tablets, Schering Corporation
Serzone (nefazodone hydrochloride) Tablets, Bristol-Myers Squibb Company
Tensilon (edrophonium chloride) Injection, ICN Pharmaceuticals, Inc.
Patent Term Extension and New Patents Docket Number *95S-0117
http://www.fda.gov/cder/orange/docket.pdf

April 25, 2002

FDA Drug Approvals List http://www.fda.gov/cder/da/da.htm
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
FASLODEX (fulvestrant) Injection, AstraZeneca Pharmaceuticals
The System to Manage Accutane Related Teratogenicity (S.M.A.R.T.) Guide to
Best Practices. http://www.fda.gov/cder/drug/infopage/accutane/smart.pdf

April 24, 2002

Tentative Advisory Committee Meetings, CDER
http://www.fda.gov/cder/meeting/advisorycomyear.htm

April 23, 2002

Drug Master Files http://www.fda.gov/cder/dmf/index.htm

April 22, 2002

KI in Radiation Emergencies-Questions and Answers [HTML]
http://www.fda.gov/cder/guidance/5052fnl.htm or [PDF]
http://www.fda.gov/cder/guidance/5052fnl.pdf
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Children's Advil Cold, Wyeth Consumer Healthcare
Diltiazem Hydrochloride Injection, Gensia Sicor Pharmaceuticals, Inc.
Maxalt (rizatritpan benzoate) Tablets & Maxalt-MLT (orally disintegrating
tablet), Merck
Nutropin AQ (somatropin [rDNA origin] injection), Genentech, Inc.
Phenytoin Oral Suspension USP, Morton Grove Pharmaceuticals, Inc.
Protonix (pantoprazole sodium) Delayed-Release Tablets, Wyeth-Ayerst
Laboratories
Reminyl (galantamine hydrobromide) Tablets & Oral Suspension, Johnson &
Johnson Pharmaceutical Research & Development, L.L.C.
Zarontin (ethosuximide) Capsules, Pfizer Inc.
Prescription Drug User Fee Act (PDUFA) FY 2001 Performance Report
http://www.fda.gov/oc/pdufa/report2001/pdufareport.html


Drug Information (Updated 4/19/2002)

April 15, 2002

April 8-12, 2002, Generic Pharmaceutical Association Annual Meeting and
Educational Conference - Presentations
http://www.fda.gov/cder/ogd/index.htm#New
Labeling Updates
http://www.fda.gov/cder/ogd/rld/labeling_review_branch.html
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Accutane (isotretinoin) Capsules, Hoffmann-La Roche Inc.
ADDERALL CII (Mixed Salts of a Single-Entity Amphetamine Product) Tablets,
Shire Pharmaceutical Development Inc.
Ceftin (cefuroxime axetil) Tablets and Oral Suspension, GlaxoSmithKline
Cerumex (triethanolamine polypeptide oleate-condensate otic solution), The
Purdue Frederick Company
Novolin R, N, & 70/30 (Human Insulin [rDNA Origin & Isophane), Novo Nordisk
Pharmaceuticals, Inc. supp32
Novolin R, N, & 70/30 (Human Insulin [rDNA Origin & Isophane), Novo Nordisk
Pharmaceuticals, Inc. supp 33
NovoLog (insulin aspart [rDNA origin]) Injection, Novo Nordisk supp2
NovoLog (insulin aspart [rDNA origin]) Injection, Novo Nordisk supp4
Sporanox (itraconazole) Capsules, Johnson and Johnson Pharmaceutical
Research and Development. L.L.C.
Trusopt (dorzolamide hydrochloride ophthalmic solution), Merck & Co., Inc.
Vioxx (rofecoxib) Tablets & Suspension, Merck & Co. Inc.


April 16, 2002

Approved Active Moieties to which FDA has Issued a Written Request for
Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic
Act http://www.fda.gov/cder/pediatric/wrlist.htm
Dietary supplement company signs a consent decree prohibiting the company
from making or distributing unapproved new drugs, including products
containing ephedrine hydrochloride or any synthetic ephedrine alkaloid. FDA
News. http://www.fda.gov/bbs/topics/NEWS/2002/NEW00802.html
Generic Drug Approvals for March 2002
Approvals http://www.fda.gov/cder/ogd/approvals/AP0302.htm
First-Time Generics http://www.fda.gov/cder/ogd/approvals/1st0302.htm
Tentative Approvals http://www.fda.gov/cder/ogd/approvals/TA0302.htm
Human Drug Advisory Committee Rosters (Updated)
http://www.fda.gov/cder/audiences/acspage/acslist1.htm
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Akineton (biperiden) Tablet, Abbott Laboratories
Amaryl (glimepiride Tablets, Aventis Pharmaceuticals
Amiodarone Hydrochloride Injection, Faulding Pharmaceutical Co., Tentatively
Approved
Carnitor (levocarnitine) Tablets, Oral Solution & Injection, Sigma-Tau
Pharmaceuticals, Inc.
Clarinex (Deloratadine) Tablets, Schering Corporation
Embeline Gel, 0.05% (Clobetasol Propionate Gel, 0.05%, Healthpoint, Ltd.
Hydroxyzine Hydrochloride Syrup USP, Vintage Pharmaceuticals, Inc.
Miradon (anisindione) Tablets, Schering Corporation
Potassium Chloride Extended-release Tablets USP, Andrx Pharmaceuticals, Inc.
Prednisolone Syrup USP, KV Pharmaceutical Company
Tranxene (clorazepate dipotassium) dosages, Abbott Laboratories
Trizivir (abacavir sulfate, lamivudine, zidovudine), GlaxoSmithKline
Valium (diazepam) Tablets & Injection, Roche Products Inc.
Patent Term Extension and New Patents Docket Number *95S-0117
http://www.fda.gov/cder/orange/docket.pdf
Pediatric Exclusivity Statistics as of February 1, 2002
http://www.fda.gov/cder/pediatric/wrstats.htm
Pediatric Labeling Changes effected under Section 505A of the Federal Food,
Drug, and Cosmetic Act as of February 15, 2002
http://www.fda.gov/cder/pediatric/labelchange.htm

April 17, 2002

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Agenerase (amprenavir) Capsules and Oral Solution, GlaxoSmithKline
BuSpar (Buspirone Hydrochloride) Tablets, Bristol-Myers Squibb Co.
Cafcit (caffeine citrate) Injection & Oral Solution, O.P.R. Development,
L.P.
Ethamolin (ethanolamine oleate) Injection, Questcor Pharmaceuticals, Inc.
Innohep (tinzaparin sodium) Injection, Bristol-Myers Squibb Pharma Company
Minocin (minocycline hydrochloride) Oral Suspension, Wyeth-Ayerst Research
Minocin (minocycline hydrochloride) Pellet-Filled Capsules, Wyeth-Ayerst
Research
Motrin Suspension, Chewable Tablets, Caplets & Oral Drops, McNeil Consumer
Healthcare
Pravachol (Pravastatin Sodium) Tablets, Bristol-Myers Squibb
Rocaltrol (calcitriol) Capsules & Oral Solution, Hoffmann-LaRoche Inc.
VIRACEPT (nelfinavir mesylate) Tablets and Oral Powder, Agouron
Pharmaceuticals, Inc.
Zoladex (goserelin acetate) Implant, AstraZeneca Pharmaceuticals LP
Zoladex (goserelin acetate) Implant, AstraZeneca Pharmaceuticals LP


April 18, 2002

Comprehensive List of Guidance Documents
http://www.fda.gov/cder/guidance/guidlist.pdf

FDA approves new labeling information for Cytotec (misoprostol). Cytotec
Label. (4/17/2002) http://www.fda.gov/cder/foi/label/2002/19268slr037.pdf

FDA alerts healthcare professionals about new safety information on Mifeprex
(mifepristone). Mifepristone Information. (4/17/2002)
http://www.fda.gov/cder/drug/infopage/mifepristone/default.htm

International Conference on Harmonization: Electronic Standards for the
Transfer of Regulatory Information http://www.fda.gov/cder/m2/default.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Amoxicillin & Clavulanate Potassium Tablets USP, Geneva Pharmaceuticals,
Inc., posted 4/18/02
Celontin (methsuximide) Capsules, Parke-Davis Pharmaceuticals Limited,
posted 4/18/02
Cipro (Ciprofloxacin Hydrochloride) Tablets & Cipro (ciprofloxacin) Oral
Suspension, Bayer Corporation, Pharmaceutical Division, posted 4/18/02
Cipro (Ciprofloxacin) IV Solution, Bayer Corporation, Pharmaceutical
Division, posted 4/18/02
Cutivate (fluticasone propionate) Cream, GlaxoSmithKline, posted 4/18/02
Estradiol Tablets USP, USL Pharma, Inc., posted 4/18/02
Haldol (haloperidol) Tablets, Concentrate, Injection, and Haldol
(haloperidol) Decanoate Injection, The R.W. Johnson Pharmaceutical Research
Institute, posted 4/18/02
Metformin Hydrochloride Tablets, Andrx Pharmaceuticals, Inc., Tentatively
Approved, posted 4/18/02
Quixin (levofloxacin ophthalmic solution), Santen Incorporated, posted
4/18/02
Sinografin (diatrizoate meglumine and iodipimide meglumine injection),
Bracco Diagnostics, posted 4/18/02



April 19, 2002

Division of Drug Marketing, Advertising, and Communications
http://www.fda.gov/cder/ddmac/index.htm

Drug Interactions with Herbal Products & Food: Educational Symposium July
22-23, 2002, The American Society for Clinical Pharmacology and Therapeutics
(ASCPT), Bethesda, Maryland. [Agenda and Registration ]
http://www.ascpt.org/symposium411.pdf

FDA issues Public Health Advisory: Contamination of Multi-dose Bottles of
Albuterol Sulfate Solution for Inhalation (0.5%)
http://www.fda.gov/cder/drug/advisory/albuterol.htm

Labeling Updates (March 2002)
http://www.fda.gov/cder/ogd/rld/labeling_review_branch.html

New Drug Approval Reports

CDER Response to Request for Fast Track Designation
http://www.fda.gov/cder/rdmt/internetftstats.htm

Fast Track Designated Products Approved since 1998
http://www.fda.gov/cder/rdmt/internetftap.htm

NDA Approvals for Calendar Year 2000
http://www.fda.gov/cder/rdmt/NDAAPS00CY.HTM
NDA Approvals for Calendar Year 1999
http://www.fda.gov/cder/rdmt/ndaaps99cy.htm

Tentative Advisory Committee Meetings, CDER
http://www.fda.gov/cder/meeting/advisorycomyear.htm


To subscribe or unsubscribe from CDERWEEK
http://www.fda.gov/cder/cdernew/listserv.html

Drug Information (Updated 4/15/2002)

April 8-12, 2002, Generic Pharmaceutical Association Annual Meeting and
Educational Conference - Presentations
http://internet-dev.fda.gov/cder/ogd/index.htm#New
Labeling Updates
http://www.fda.gov/cder/ogd/rld/labeling_review_branch.html
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Accutane (isotretinoin) Capsules, Hoffmann-La Roche Inc.
ADDERALL CII (Mixed Salts of a Single-Entity Amphetamine Product) Tablets,
Shire Pharmaceutical Development Inc.
Ceftin (cefuroxime axetil) Tablets and Oral Suspension, GlaxoSmithKline
Cerumex (triethanolamine polypeptide oleate-condensate otic solution), The
Purdue Frederick Company
Novolin R, N, & 70/30 (Human Insulin [rDNA Origin & Isophane), Novo Nordisk
Pharmaceuticals, Inc. supp32
Novolin R, N, & 70/30 (Human Insulin [rDNA Origin & Isophane), Novo Nordisk
Pharmaceuticals, Inc. supp 33
NovoLog (insulin aspart [rDNA origin]) Injection, Novo Nordisk supp2
NovoLog (insulin aspart [rDNA origin]) Injection, Novo Nordisk supp4
Sporanox (itraconazole) Capsules, Johnson and Johnson Pharmaceutical
Research and Development. L.L.C.
Trusopt (dorzolamide hydrochloride ophthalmic solution), Merck & Co., Inc.
Vioxx (rofecoxib) Tablets & Suspension, Merck & Co. Inc.


April 16, 2002

Approved Active Moieties to which FDA has Issued a Written Request for
Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic
Act http://www.fda.gov/cder/pediatric/wrlist.htm
Dietary supplement company signs a consent decree prohibiting the company
from making or distributing unapproved new drugs, including products
containing ephedrine hydrochloride or any synthetic ephedrine alkaloid. FDA
News. http://www.fda.gov/bbs/topics/NEWS/2002/NEW00802.html
Generic Drug Approvals for March 2002
Approvals http://www.fda.gov/cder/ogd/approvals/AP0302.htm
First-Time Generics http://www.fda.gov/cder/ogd/approvals/1st0302.htm
Tentative Approvals http://www.fda.gov/cder/ogd/approvals/TA0302.htm
Human Drug Advisory Committee Rosters (Updated)
http://www.fda.gov/cder/audiences/acspage/acslist1.htm
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Akineton (biperiden) Tablet, Abbott Laboratories
Amaryl (glimepiride Tablets, Aventis Pharmaceuticals
Amiodarone Hydrochloride Injection, Faulding Pharmaceutical Co., Tentatively
Approved
Carnitor (levocarnitine) Tablets, Oral Solution & Injection, Sigma-Tau
Pharmaceuticals, Inc.
Clarinex (Deloratadine) Tablets, Schering Corporation
Embeline Gel, 0.05% (Clobetasol Propionate Gel, 0.05%, Healthpoint, Ltd.
Hydroxyzine Hydrochloride Syrup USP, Vintage Pharmaceuticals, Inc.
Miradon (anisindione) Tablets, Schering Corporation
Potassium Chloride Extended-release Tablets USP, Andrx Pharmaceuticals, Inc.
Prednisolone Syrup USP, KV Pharmaceutical Company
Tranxene (clorazepate dipotassium) dosages, Abbott Laboratories
Trizivir (abacavir sulfate, lamivudine, zidovudine), GlaxoSmithKline
Valium (diazepam) Tablets & Injection, Roche Products Inc.
Patent Term Extension and New Patents Docket Number *95S-0117
http://www.fda.gov/cder/orange/docket.pdf
Pediatric Exclusivity Statistics as of February 1, 2002
http://www.fda.gov/cder/pediatric/wrstats.htm
Pediatric Labeling Changes effected under Section 505A of the Federal Food,
Drug, and Cosmetic Act as of February 15, 2002
http://www.fda.gov/cder/pediatric/labelchange.htm

April 17, 2002

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Agenerase (amprenavir) Capsules and Oral Solution, GlaxoSmithKline
BuSpar (Buspirone Hydrochloride) Tablets, Bristol-Myers Squibb Co.
Cafcit (caffeine citrate) Injection & Oral Solution, O.P.R. Development,
L.P.
Ethamolin (ethanolamine oleate) Injection, Questcor Pharmaceuticals, Inc.
Innohep (tinzaparin sodium) Injection, Bristol-Myers Squibb Pharma Company
Minocin (minocycline hydrochloride) Oral Suspension, Wyeth-Ayerst Research
Minocin (minocycline hydrochloride) Pellet-Filled Capsules, Wyeth-Ayerst
Research
Motrin Suspension, Chewable Tablets, Caplets & Oral Drops, McNeil Consumer
Healthcare
Pravachol (Pravastatin Sodium) Tablets, Bristol-Myers Squibb
Rocaltrol (calcitriol) Capsules & Oral Solution, Hoffmann-LaRoche Inc.
VIRACEPT (nelfinavir mesylate) Tablets and Oral Powder, Agouron
Pharmaceuticals, Inc.
Zoladex (goserelin acetate) Implant, AstraZeneca Pharmaceuticals LP
Zoladex (goserelin acetate) Implant, AstraZeneca Pharmaceuticals LP


April 18, 2002

Comprehensive List of Guidance Documents
http://www.fda.gov/cder/guidance/guidlist.pdf

FDA approves new labeling information for Cytotec (misoprostol). Cytotec
Label. (4/17/2002) http://www.fda.gov/cder/foi/label/2002/19268slr037.pdf

FDA alerts healthcare professionals about new safety information on Mifeprex
(mifepristone). Mifepristone Information. (4/17/2002)
http://www.fda.gov/cder/drug/infopage/mifepristone/default.htm

International Conference on Harmonization: Electronic Standards for the
Transfer of Regulatory Information http://www.fda.gov/cder/m2/default.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Amoxicillin & Clavulanate Potassium Tablets USP, Geneva Pharmaceuticals,
Inc., posted 4/18/02
Celontin (methsuximide) Capsules, Parke-Davis Pharmaceuticals Limited,
posted 4/18/02
Cipro (Ciprofloxacin Hydrochloride) Tablets & Cipro (ciprofloxacin) Oral
Suspension, Bayer Corporation, Pharmaceutical Division, posted 4/18/02
Cipro (Ciprofloxacin) IV Solution, Bayer Corporation, Pharmaceutical
Division, posted 4/18/02
Cutivate (fluticasone propionate) Cream, GlaxoSmithKline, posted 4/18/02
Estradiol Tablets USP, USL Pharma, Inc., posted 4/18/02
Haldol (haloperidol) Tablets, Concentrate, Injection, and Haldol
(haloperidol) Decanoate Injection, The R.W. Johnson Pharmaceutical Research
Institute, posted 4/18/02
Metformin Hydrochloride Tablets, Andrx Pharmaceuticals, Inc., Tentatively
Approved, posted 4/18/02
Quixin (levofloxacin ophthalmic solution), Santen Incorporated, posted
4/18/02
Sinografin (diatrizoate meglumine and iodipimide meglumine injection),
Bracco Diagnostics, posted 4/18/02



April 19, 2002

Division of Drug Marketing, Advertising, and Communications
http://www.fda.gov/cder/ddmac/index.htm

Drug Interactions with Herbal Products & Food: Educational Symposium July
22-23, 2002, The American Society for Clinical Pharmacology and Therapeutics
(ASCPT), Bethesda, Maryland. [Agenda and Registration ]
http://www.ascpt.org/symposium411.pdf

FDA issues Public Health Advisory: Contamination of Multi-dose Bottles of
Albuterol Sulfate Solution for Inhalation (0.5%)
http://www.fda.gov/cder/drug/advisory/albuterol.htm

Labeling Updates (March 2002)
http://www.fda.gov/cder/ogd/rld/labeling_review_branch.html

New Drug Approval Reports

CDER Response to Request for Fast Track Designation
http://www.fda.gov/cder/rdmt/internetftstats.htm

Fast Track Designated Products Approved since 1998
http://www.fda.gov/cder/rdmt/internetftap.htm

NDA Approvals for Calendar Year 2000
http://www.fda.gov/cder/rdmt/NDAAPS00CY.HTM
NDA Approvals for Calendar Year 1999
http://www.fda.gov/cder/rdmt/ndaaps99cy.htm

Tentative Advisory Committee Meetings, CDER
http://internet-dev/cder/meeting/advisorycomyear.htm


To subscribe or unsubscribe from CDERWEEK
http://www.fda.gov/cder/cdernew/listserv.html


Drug Information (Updated 4/11/2002)

FDA warns that nicotine lollipops and nicotine lip balm are illegal, and may
pose health risks. FDA Talk Paper
http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01144.html
National Drug Code Directory Searchable Database
http://www.fda.gov/cder/ndc/database/default.htm
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
DRUG APPROVAL PACKAGES
AntagonÔ (ganirelix acetate), Drug Approval Package, posted 4/11/02
Atacand (candesartan cilexetil) Tablets, Drug Approval Package, posted
4/11/02
Bextra (Valdecoxib) Tablets, Drug Approval Package, posted 4/11/02
Exelon (rivastigmine tartrate) Oral Solution, Drug Approval Package, posted
4/11/02
Lotemax (Loteprednol Etabonate), Drug Approval Package, posted 4/11/02
Prilosec (omeprazole) Delayed-Release Capsules, Drug Approval Package,
posted 4/11/02
Targretin (bexarotene) capsules, Drug Approval Package, posted 4/11/02
Welchol (colesevelam hydrochloride), Drug Approval Package, posted 4/11/02

April 12, 2002

FDA's approval for the use of Vioxx to treat rheumatoid arthritis is
accompanied by new labeling on the risks and benefits of this drug. FDA
Talk Paper.
http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01145.html
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Amoxil (amoxicillin), GlaxoSmithKline
Augmentin (amoxicillin/clavulanate potassium) Tablets, Powder, Chewables,
BID Tablets, Powder & BID Chewables, GlaxoSmithKline
Megace (megestrol acetate) Oral Suspension, Bristol Myers Squibb Co.
Propecia (finasteride) Tablets, Merck & Company, Inc.
Infasurf (calfactant) Intratracheal Suspension, Drug Approval Package,
posted 4/12/02

April 11, 2002

FDA warns that nicotine lollipops and nicotine lip balm are illegal, and may
pose health risks. FDA Talk Paper
http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01144.html
National Drug Code Directory Searchable Database
http://www.fda.gov/cder/ndc/database/default.htm
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
DRUG APPROVAL PACKAGES
AntagonÔ (ganirelix acetate), Drug Approval Package, posted 4/11/02
Atacand (candesartan cilexetil) Tablets, Drug Approval Package, posted
4/11/02
Bextra (Valdecoxib) Tablets, Drug Approval Package, posted 4/11/02
Exelon (rivastigmine tartrate) Oral Solution, Drug Approval Package, posted
4/11/02
Lotemax (Loteprednol Etabonate), Drug Approval Package, posted 4/11/02
Prilosec (omeprazole) Delayed-Release Capsules, Drug Approval Package,
posted 4/11/02
Targretin (bexarotene) capsules, Drug Approval Package, posted 4/11/02
Welchol (colesevelam hydrochloride), Drug Approval Package, posted 4/11/02

April 10, 2002

Approved Drug Products with Therapeutic Equivalence: Query
http://www.fda.gov/cder/ob/default.htm
Investigational Human Drugs Clinical Investigator Inspection List
http://www.fda.gov/cder/regulatory/investigators/default.htm
National Drug Code (NDC) Directory http://www.fda.gov/cder/ndc/index.htm
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
DRUG APPROVAL PACKAGES
Actonel (risedronate sodium) Tablet, Drug Approval Package, posted 4/10/02
Azopt (Briazolamide) Ophthalmic Suspension, Drug Approval Package, posted
4/10/02
LEVULAN® KERASTICK (aminolevulinic acid HCl) for Topical Solution, Drug
Approval Package, posted 4/10/02
Lipitor (atorvastatin calcium) Tablets, Drug Approval Package, posted
4/10/02
Refludan (Lepirudin) Injection, Drug Approval Package, posted 4/10/02
Solage (mequinol, 2%/tretinoin, 0.01%) Topical Solution, Drug Approval
Package, posted 4/10/02
Vitravene Injection (fomivirsen sodium intravitreal injectable), Drug
Approval Package, posted 4/10/02

April 9, 2002

Accutane Medication Guide. (Updated)
http://www.fda.gov/cder/drug/infopage/accutane/medicationguide.htm
AERS Electronic Submissions http://www.fda.gov/cder/aerssub/default.htm
CDER Advisory Committee Staff (Updated)
http://www.fda.gov/cder/audiences/acspage/acsPOClist1.htm
CDER Organization Charts
Center for Drug Evaluation Research Organizational Chart
http://www.fda.gov/cder/cderorg/cder.pdf
Office of Center Director http://www.fda.gov/cder/cderorg/ocd.pdf
Office of Pharmaceutical Sciences http://www.fda.gov/cder/cderorg/ops.pdf
Office of Pharmacoepidemiology and Statistical Science
http://www.fda.gov/cder/cderorg/OPSS.PDF
Office of New Drugs http://www.fda.gov/cder/cderorg/OND.PDF
Creating New Knowledge, FDA & Industry in Dialogue. A conference between FDA
and industry, sponsored by Temple University School of Pharmacy. April 17,
2002. Wyndham Franklin Plaza Hotel, Philadelphia, Pennsylvania. [Agenda and
Registration] http://www.temple.edu/pharmacy_QARA/fda.html
Drug Shortage: Drug Experiencing Limited Distribution: LACRISERT 4/9/2002
http://www.fda.gov/cder/drug/shortages/default.htm#Limited
IND Exemptions for Studies of Lawfully Marketed Cancer Drug or Biological
Products [PDF] http://www.fda.gov/cder/guidance/3760dft.pdf
Medical Gas Warning Letters Listing (updated)
http://www.fda.gov/cder/dmpq/medacts/MEDICAL.html
NDA Approvals for Calendar Year 2000
http://www.fda.gov/cder/rdmt/NDAAPS00CY.HTM
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Remeron (mirtazapine) Tablets, Organon Inc.
Tamiflu (oseltamivir phosphate) capsules and oral suspension, Hoffman-La
Roche Inc.
Trusopt (dorzolamide hydrochloride ophthalmic solution), Merck & Co., Inc.
Fenofibrate Capsules (Micronized), Novopharm Limited, Tentatively Approved
Recognizing Psychiatric Disorders in Adolescents and Yound Adults: A Guide
for Prescribers of Accutane (insotretinoin)
http://www.fda.gov/cder/drug/infopage/accutane/accutane_psychdisorders.htm
Roster of the Anti-Infective Drugs Advisory Committee (Updated)
http://internet-dev.fda.gov/cder/audiences/acspage/antiinfective_roster1

April 8, 2002

Approved Drug Products with Therapeutic Equivalence Evaluations: Orange Book
- 22nd Annual Edition
http://www.fda.gov/cder/orange/adp.htm
Approved Drug Products with Therapeutic Equivalence Evaluations-22nd Edition
(Cumulative Supplement-1)
http://www.fda.gov/cder/orange/supplement/cspreface.htm
[Information and Data Files]
http://www.fda.gov/cder/orange/obreadme.htm
Approved Drug Products with Therapeutic Equivalence Evaluations Monthly
Additions and Deletions (January)
http://www.fda.gov/cder/rxotcdpl/pdpl_200201.htm
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP, Pharmaceutical
Formulations, Inc.


Drug Information (Updated 3/29/2002)

-------------------------------------------------

Generic Drug Approvals for February 2002
Approvals
http://www.fda.gov/cder/ogd/approvals/AP0202.htm
First-Time Generics
http://www.fda.gov/cder/ogd/approvals/1stgen0202.htm
Tentative Approvals
http://www.fda.gov/cder/ogd/approvals/TA0202.htm
FDA Drug Approvals List
http://www.fda.gov/cder/da/da.htm
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Blocadren (Timolol Maleate) Tablets, Merck & Co., Inc.
Ceftin (cefuroxime axetil) Tablets and Oral Suspension, GlaxoSmithKline
Fortaz (ceftazidime) Injection, Fortaz (ceftazidime sodium) Injection,
Ceptaz® (ceftazidime) Injection (L-arginine formulation), GlaxoSmithKline
Hydrochlorothiazide Tablets, Vintage Pharmaceuticals Inc.
Methadose (Methadone Hydrochloride) Oral Concentrate, USP, Mallinckrodt, Inc

Micort-HC Lipocream (Hydrocortisone Acetate Cream USP), Ferndale
Laboratories, Inc.
Pamidronate Disodium Injection, Gensia Sicor Pharmaceuticals, Inc.
Viramune (Nevirapine) Tablets & Oral Solution, Boehringer Ingelheim
Pharmaceuticals, Inc.
ZERIT (stavudine) Capsules and Pediatric Oral Solution (POS), Bristol-Myers
Squibb Company
Zosyn (Sterile Piperacillin Sodium & Tazobacam Sodium) Injection,
Wyeth-Ayerst Research
March 2002 Cyber Letters
http://www.fda.gov/cder/warn/cyber/cyber2002.htm
FDA's New Approach to Plant Inspections: Systems Inspections 2002 - An
FDA/Industry Workshop. Three sessions offered: 6/17/2002, 7/15/2002, and
8/5/2002. Federal Register
http://www.fda.gov/OHRMS/DOCKETS/98fr/032902b.pdf
notice.
[Agenda and Registration ]
http://www.chpa-info.org/meetings/pdfs/2002Workshops_Updated_22602
PET Drug Products - Current Good Manufacturing Practice (CGMP) [HTML]
http://www.fda.gov/cder/guidance/4259dft.htm
or [PDF]
http://www.fda.gov/cder/guidance/4259dft.pdf
FDA and Bristol-Myers Squibb notify healthcare providers caring for persons
with HIV of the potential for lactic acidosis as a complication of therapy
with Zerit (stavudine), d4T. MedWatch Safety Information
http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#zerit

March 28, 2002

Comprehensive List of Guidance Documents
http://www.fda.gov/cder/guidance/guidlist.pdf
Sea Miembro Activo del Equipo de Cuidados de la Salud (Spanish version of
"Be an Active Member of Your Health Care Team")
http://www.fda.gov/cder/consumerinfo/activeMember_Spanish.htm

March 27, 2002

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
DRUG APPROVAL PACKAGES
Alocril (nedocromil sodium ophthalmic solution), Drug Approval Package
ZADITOR (ketotifen fumarate ophthalmic solution), Drug Approval Package

March 26, 2002

FDA notifies healthcare professionals and consumers of the potential risk of
severe liver injury associated with the use of kava-containing dietary
supplements.
http://www.cfsan.fda.gov/~dms/addskava.html
Poster - Medical Gas Mix-Ups: Take a look before you hook. Spanish
language version
http://www.fda.gov/cder/dmpq/chgmedgx022502.pdf
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Aleve (naproxen sodium), Bayer Consumer Care Division
Azactam (aztreonam for injection) & Azactam (aztreonam injection),
Bristol-Myers Squibb
Fortaz (ceftazidime sodium) Injection Fortaz (ceftazidime) Injection,
GlaxoSmithKline
Heparine Sodium Injection, USP and Heparin Lock Flush Solution, USP,
American Pharmaceutical Partners, Inc.
Purinethol (mercaptopurine) Tablets, SmithKlineBeecham dba GlaxoSmithKline
Serevent Diskus (salmeterol xinafoate inhalation powder), GlaxoSmithKline
Famotidine Tablets USP, L. Perrigo Co., Tentatively Approved


Drug Information (Updated 3/21/2002)

-------------------------------------------------

Approved Active Moieties to which FDA has Granted Exclusivity for Pediatric
Studies under Section 505A of the Federal Food, Drug, and Cosmetic Act
http://www.fda.gov/cder/pediatric/exgrant.htm
Drug Shortages; Current Drug Shortage: Pipracil (piperacillin sodium) Powder
for Injection
http://www.fda.gov/cder/drug/shortages/default.htm#Current
Drug Shortages; Drugs Experiencing Limited Distribution: Zosyn (piperacillin
sodium and tazobactam sodium) Powder for Injection
http://www.fda.gov/cder/drug/shortages/default.htm#Limited
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
AN-DTPA Kit (for the Preparation of Technetium Tc99m Pentetate Injection
Diagnostic for Intravenous Use), CIS-US, Inc.
Avinza (morphine sulfate extended-release) Capsules, Elan Drug Delivery,
Inc.
Lacrisert (Hydroxypropyl Cellulose Ophthalmic Insert) Sterile, Merck & Co.,
Inc.
Mesnex (mesna) Tablets, Bristol-Myers Squibb.
Midamor (amiloride hydrochloride) 5 mg Tablets and Moduretic (amiloride
hydrochloride and hydrochlorothiazide) 5/50 mg Tablets, Merck & Co., Inc.
Monodox (doxycycline monohydrate) Capsules, Watson Laboratories, Inc.
Nicotrol TD (nicotine transdermal system), Pharmacia Consumer Healthcare
ProAmatine (midodrine hydrochloride) Tablets, Shire Laboratories Inc.
TOBI (tobramycin solution for inhalation), Chiron Corporation
Zocor (simvastatin) Tablets, Merck & Co., Inc.
Oncology Tools Update: What's New
http://www.fda.gov/cder/cancer/whatsnew.htm


March 20, 2002

Drug Shortage; Drug to be Discontinued: Geref (sermorelin acetate for
injection)
http://www.fda.gov/cder/drug/shortages/default.htm#disc
Drug Shortage; Drug to be Discontinued: Priscoline hydrochloride ampules
(tolazoline hydrochloride injection)
http://www.fda.gov/cder/drug/shortages/default.htm#disc
Tentative Advisory Committee Meeting Dates as of March 11, 2002
http://www.fda.gov/cder/meeting/advisorycomyear.htm
Patent Term Extension and New Patents Docket Number *95S-0117
http://www.fda.gov/cder/orange/docket.pdf


March 19, 2002

Cumulative Prescription and OTC Drug Product Patent and Exclusivity Data
http://www.fda.gov/cder/orange/22bookpub.pdf
FDA issues Guidance for Industry: Information Program on Clinical Trials for
Serious or Life-Threatening Diseases and Conditions. The Guidance
http://www.fda.gov/cder/guidance/4856.htm
Efficacy Supplements Approved in Calendar Year 2001
http://www.fda.gov/cder/rdmt/Escy01ap.htm
Efficacy Supplements Approved in Calendar Year 2000
http://www.fda.gov/cder/rdmt/esap2000.htm
Efficacy Supplements Approved in Calendar Year 1999
http://www.fda.gov/cder/rdmt/escy99ap.htm
Efficacy Supplements Approved in Calendar Year 1998
http://www.fda.gov/cder/rdmt/eff98.htm

FDA Drug Approvals List
http://www.fda.gov/cder/da/da.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Acetaminophen Extended-release Tablets, Coerpharma LLC
Ampicillin and Sulbactam Injection USP, ESI Lederle
Asimia (paroxetine mesylate) Tablets, Synthon Pharmaceuticals Ltd.
Desonide Lotion, Altana Inc.
Timentin (sterile ticarcillin disodium and clavulanate potassium) Injection
& Galaxy Plastic Container, GlaxoSmithKline


March 18, 2002

Information Program on Clinical Trials for Serious or Life-Threatening
Diseases and Conditions [HTML] or [PDF] (Issued 3/2002, Posted 3/18/2002)
http://www.fda.gov/cder/guidance/4856FNL.PDF

Cyber Letters 2002
http://www.fda.gov/cder/warn/cyber/cyber2002.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Erythromycin Topical Gel USP, Glades Pharmaceuticals, Inc.
Fludrocortisone Acetate Tablets USP, IMPAX Laboratories, Inc.
Mometasone Furoate Ointment USP, Clay-Park Labs, Inc.
Sodium Phosphates Injection, USP, Abbott Laboratories
DRUG APPROVAL PACKAGES

Angiomax (bivalirudin) Injection, Drug Approval Package
Lantus (insulin glargine [rDNA origin] injection), Drug Approval Package
Starlix (nateglinide) Oral Tablets, Drug Approval Package


Drug Information (Updated 3/15/2002)

-------------------------------------------------

Inhalational Anthrax (Post Exposure) -- Developing Antimicrobial Drugs
(Issued 3/15/2002)
http://www.fda.gov/cder/guidance/4848dft.PDF
Studies Breakdown Report for Issued Written Requests as of 3/1/2002:
Pediatric Exclusivity
http://www.fda.gov/cder/pediatric/breakdown.htm
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Amoxicillin & Clavulanate Potassium Tablets USP, Geneva Pharmaceuticals,
Inc.
Didronel (Etidronate Disodium) Tablets, Procter and Gamble Pharmaceuticals,
Inc.
Midazolam Hydrochloride Syrup, Ranbaxy Laboratories Ltd.
Minoxidil Topical Solution USP (for Men) 5% Solution, Clay-Park Labs, Inc.
Sodium Chloride Injection, USP, Abbott Laboratories

March 14, 2002

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Amoxicillin & Clavulanate Potassium Tablets USP, Geneva Pharmaceuticals,
Inc.
Buspirone Hydrochloride Tablets USP, Egis Pharmaceuticals, Ltd.
Galzin (Zinc Acetate) Capsules, TEVA Pharmaceuticals USA
Ibuprofen Tablets USP, L. Perrigo Company
Norvir (Ritonavir) Soft gel Capsules & Oral Solution, Abbott Laboratories
Olux (clobetasol propionate) Foam, Connetics Corporation
Rescriptor (delavirdine) Tablet, Agouron Pharmaceuticals Inc.
SYNERCID I.V. (quinupristin and dalfopristin for injection), Rhone Poulenc
Rorer Pharmaceuticals
Tenex (guanfacine hydrochloride) Tablets, A. H. Robbins
Visicol (sodium phosphate monobasic monohydratde, USP and sodium phosphate
dibasic anhydrous, USP) Tablets, InKine Pharmaceutical Company, Inc.
Zithromax (azithromycin for injection), I.V., Pfizer, Inc.

March 13, 2002

Cytovene (ganciclovir) Updated 3/13/2002
http://www.fda.gov/cder/drug/shortages/default.htm#current
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Buspirone Hydrochloride Tablets USP, Watson Laboratories, Inc.

March 12, 2002

Labeling Updates
http://www.fda.gov/cder/ogd/rld/labeling_review_branch.html

Workshop On Pharmacogenetics/Pharmacogenomics In
Drug Development and Regulatory Decision-Making, May 16-17, 2002
http://www.fda.gov/cder/calendar/meeting/phrma52002/default.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Actiq (oral transmucosal fentanyl citrate), Anesta Corporation
Alocril (nedocromil sodium) Ophthalmic Solution, Allergan, Inc.
Butorphanol Tartrate Nasal Spray, Roxane Laboratories, Inc.
Curosurf (poractant alfa) Intratracheal Suspension, Dey L.P.
Famotidine Tablets USP, Torpharm
Hycamtin (topotecan hydrochloride) for Injection, SmithKline Beecham
Lioresal (Baclofen) Injection, Medtronic Drug Delivery
Rebetol (ribavirin) Capsules, Schering Corporation
Risperdal (risperidone) Tablets, Johnson & Johnson Pharmaceutical Research &
Development, L.L.C.
Toprol XL (Metoprolol Succinate) Tablets, AstraZeneca
Tentative Approval
Nizatidine Capsules USP, Eon Labs Manufacturing, Inc., Tentative Approval

DRUG APPROVAL PACKAGES
EVOXAC (cevimeline HCl) Capsules, Drug Approval Package, posted 3/12/02
Myoview (Kit for the Preparation of Technetium Tc99m Tetrofosmin Injection),
Drug Approval Package, posted 3/12/02

March 11, 2002

FDA Consumer magazine Latest: March-April 2002
http://www.fda.gov/fdac/202_toc.html

FDA Drug Approvals List
http://www.fda.gov/cder/da/da.htm


Drug Information (Updated 3/06/2002)

-------------------------------------------------

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Cenestin (synthetic conjugated estrogens, A), Barr Laboratories, Inc.
CIS-PYRO (Kit for the Preparation of Technetium Tc99m Pyrophosphate),
CIS-US, Inc.
Copaxone (glatiramer acetate) injection, TEVA Pharmaceuticals USA
Luxiq (betamethasone valerate) Foam, Connetics Corporation
Malarone (atovaquone and proguanil hydrochloride) Tablets, GlaxoSmithKline
Plavix (clopidogrel bisulfate) Tablets, Sanofi-Synthelabo Inc.
Procardia (nifedipine) Capsules, Pfizer Inc.
Sporanox (itraconazole) Injection, Johnson and Johnson Pharmaceutical
Research and Development. L.L.C.
Uniretic (moexipril hydrochloride/hydrochlorothiazide) Tablets, Schwarz
Pharma, Inc.
Valium (diazepam) Tablets, Hoffmann-La Roche Inc.


March 6, 2002

Drug Shortages: TABLOID brand Thioguanine
http://www.fda.gov/cder/drug/shortages/default.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Ifosfamide Injection/Mesna Injection Kit, Gensia Sicor Pharmaceuticals, Inc.

Klonopin (clonazepam) Tablets, Hoffman-La Roche Inc.
Minocin (minocycline hydrochloride) Intravenous, Wyeth-Ayerst Research
Neurontin (gabapentin) Capsules, Tablets, and Oral Solution, Pfizer Inc.
Pepcid AC (famotidine) Chewable Tablets, Merck & Co., Inc.
Pepcid AC Film Coated Tablets, Merck & Co., Inc.
Videx EC (didanosine) Delayed Release Capsules, Bristol-Myers Squibb
Ziagen (abacavir sulfate) Tablets and Oral Solution, GlaxoSmithKline
Zomig (zolmitriptan) tablets, AstraZeneca Pharmaceuticals LP
Zovirax (Acylcovir Sodium) Injection, GlaxoSmithKline


March 5, 2002

Approved Drug Products with Therapeutic Equivalence Evaluations Monthly
Additions and Deletions (December) (3/5/2002)
http://www.fda.gov/cder/rxotcdpl/pdpl_200112.htm

Approved Drug Products with Therapeutic Equivalence Evaluations-21st Edition
(Cumulative Supplement-12)
http://www.fda.gov/cder/orange/supplement/cspreface.htm
[Information and Data Files]
http://www.fda.gov/cder/orange/obreadme.htm

CDER Organization Charts (3/5/2002)
Center for Drug Evaluation Research Organizational Chart
http://www.fda.gov/cder/cderorg/cder.pdf
Office of Center Director
http://www.fda.gov/cder/cderorg/ocd.pdf
Office of Pharmaceutical Sciences
http://www.fda.gov/cder/cderorg/ops.pdf
Office of Pharmacoepidemiology and Statistical Science
http://www.fda.gov/cder/cderorg/OPSS.PDF
Office of New Drugs
http://www.fda.gov/cder/cderorg/OND.PDF

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Bicillin L-A (penicillin G benzathine suspension) Injection, Wyeth-Ayerst
Research
Bicillin C-R and Bicillin C-R 900/300 Injection, Wyeth-Ayerst Research
Coly-Mycin S Otic Suspension, Parkedale Pharmaceuticals, Inc.
Epivir (lamivudine), Tablets and Oral solution, GlaxoSmithKline
Levo-T (levothyroxine sodium tablets, USP), Mova Pharmaceutical Corporation
Pepcid AC Film Coated Tablets, Merck & Co., Inc.
Sustiva (efavirenz), Bristol-Myers Squibb Company
Zoladex (goserelin acetate) Implant, AstraZeneca Pharmaceuticals LP

DRUG APPROVAL PACKAGES
Canasa (mesalamine) Suppositories, Drug Approval Package
Elidel (Pimecorlimus) Cream, Drug Approval Package
Orfadin (Nitisinone) Capsules, Drug Approval Package
Periostat (doxycycline hyclate) Tablets, Drug Approval Package
PhosLo Gelcaps and Capsules, Drug Approval Package
Reminyl (galantamine hydrobromide) Oral Solution, Drug Approval Package
Teveten HCT Tablets, Drug Approval Package
Trileptal (oxcarbazepine) Tablets, Drug Approval Package
Viadur (leuprolide acetate implant), Drug Approval Package
Zyrtec-D 12 hr. Extended-Release Tablets (Cetirizine Hydrochloride &
Pseudoephedrine Hydrochloride), Drug Approval Package

News Along the Pike, February 2002 Issue.
http://www.fda.gov/cder/pike/janfeb2002.htm
Optional Format: PDF.
http://www.fda.gov/cder/pike/janfeb2002.pdf

Patent Term Extension and New Patents Docket Number *95S-0117
http://www.fda.gov/cder/orange/docket.pdf

 

Top

Drug Information (Updated 2/22/2002)

-------------------------------------------------

CDER Organization Charts
Center for Drug Evaluation Research Organizational Chart
http://www.fda.gov/cder/cderorg/cder.pdf
Office of Center Director
http://www.fda.gov/cder/cderorg/ocd.pdf
Office of Pharmaceutical Sciences
http://www.fda.gov/cder/cderorg/ops.pdf
Office of Pharmacoepidemiology and Statistical Science
http://www.fda.gov/cder/cderorg/OPSS.PDF
Office of New Drugs
http://www.fda.gov/cder/cderorg/OND.PDF
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
DaunoXome (daunorubicin citrate liposome injection), Gilead Sciences, Inc.
Diclofenac Potassium Tablets, Mutual Pharmaceutical Co., Inc.
Etopophos (Etoposide Phosphate), Bristol-Myers Squibb
Lactulose Solution USP, Novex Pharma
Zometa (zoledronic acid for injection) Novartis Pharmaceuticals Corporation
Tentative Approvals
Lisinopril and Hydrochlorothiazide Tablets USP, Geneva Pharmaceuticals, 2nd
Tentative Approval

February 21, 2002

FDA and Novartis have strengthened the BOXED WARNING and WARNINGS sections
of the prescribing information (PI) for Clozaril (clozapine). MedWatch 2002
Safety Information Alert for Clozaril (clozapine). (2/21/2002)
http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#clozar
Human Drugs Advisory Committees: Updated charters and roster.
http://www.fda.gov/cder/audiences/acspage/acslist1.htm
Labeling Updates
http://www.fda.gov/cder/ogd/rld/labeling_review_branch.html
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Accutane (isotretinoin) Capsules, Hoffmann-La Roche Inc.
Aciphex (Rabeprazole Sodium) Delayed-Release Tablets, Eisai Inc.
Definity, Bristol-Myers Squibb Medical Imaging, Inc.
Methotrexate Sodium Tablets, Sodium for Injection and Sodium Injection.,
Wyeth-Ayerst Laboratories
Mevacor (lovastatin) Tablets, Merck & Co., Inc.
Novantrone (mitoxantrone for Injection Concentrate), Immunex Corporation
Rebetol (ribavirin)/Intron A (interferon alfa-2b) (Rebetron Combination
Therapy, Schering Corporation
RETROVIR (zidovudine) IV Infusion, GlaxoSmithKline
RETROVIR (zidovudine) Capsules, Syrup, & Tablets., GlaxoSmithKline
RETROVIR (zidovudine) Capsules, Syrup, & Tablets., GlaxoSmithKline
Viroptic (trifluridine ophthalmic solution) 1% Sterile, Monarch
Pharmaceuticals, Inc.
Zyban (bupropion hydrochloride) extended-release tablets., GlaxoSmithKline

Phenylpropanolamine (PPA) Information Page updated
http://www.fda.gov/cder/drug/infopage/ppa/default.htm

February 20, 2002

Approved Active Moieties to which FDA has Issued a Written Request for
Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic
Act
http://www.fda.gov/cder/pediatric/wrlist.htm
Calendar of Events
http://www.fda.gov/cder/coe.htm
FDA approves Zevalin, a new therapy that for the first time includes a
monoclonal antibody that is combined with a radioactive chemical. Zevalin
is approved to treat low-grade B-cell non-Hodgkins Lymphoma.
FDA Talk Paper.
http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01138.html
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm
Cefuroxime Axetil Tablets USP, Ranbaxy laboratories Limited
Flunisolide Nasal Solution USP, Bausch & Lomb Pharmaceuticals
Ketoprofen Extended-release capsules, Mylan Pharmaceuticals Inc.
Mefloquine Hydrochloride Tablets, Geneva Pharamaceuticals
Megestrol Acetate Oral Suspension, Roxane Laboratories, Inc.
Tentative Approvals

Ciprofloxacin Ophthalmic Solution USP, Novex Pharma, Tentatively Approved
Ciprofloxacin Tablets USP, Teva Pharmaceuticals, USA, Tentatively Approved
Fenofibrate Capsules (Micronized), IMPAX Laboratories, Inc., Tentatively
Approved

Drug Information (Updated 2/15/2002)

-------------------------------------------------
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 2/15/2002)
http://www.fda.gov/cder/approval/index.htm

Paraplatin (Carboplatin) Injection, Bristol-Myers Squibb, posted 2/14/02

Prilosec (omeprazole) Delayed-Release Capsules, AstraZeneca LP, posted
2/14/02

Diclofenac Sodium Delayed-release Tablets USP, Alphapharm Pty. Ltd., posted
2/13/02

Leucovorin Calcium Injection, Xanodyne Pharmacal, Inc., posted 2/13/02

Prednisolone Sodium Phosphate Oral Solution, WE Pharmaceuticals, Inc.,
posted 2/13/02

Wellbutrin (bupropion hydrochloride) Tablets, GlaxoSmithKline, posted
2/13/02

Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets, Glaxo
Wellcome, posted 2/13/02

Paxil CR (paroxetine HCl) Tablets, GlaxoSmithKline, posted 2/12/02

Clarinex (Deloratadine) Tablets, Schering Corporation, posted 2/11/02

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine
Sulfate & Amphetamine Sulfate Tablets, Barr Laboratories, Inc., posted
2/11/02

Follistim (Follitropin Beta) Injection, Organon, Inc., posted 2/11/02

Iletin I Insulin, Lente Iletin I Insulin, and NPH Iletin I Insulin, Eli
Lilly and Company, posted 2/11/02

Lisinopril Tablets USP, Ranbaxy Laboratories Limited, 2nd Tentatively
Approved, posted 2/14/02

Lisinopril Tablets USP, Mylan Pharmaceuticals, Inc., Tentatively Approved,
posted 2/11/02


DRUG APPROVAL PACKAGES

OPTIVAR (azelastine hydrochloride ophthalmic solution), Drug Approval
Package , posted 2/15/02

Eligard (Leuprolide Acetate) Injection, Drug Approval Package , posted
2/13/02

Adderall XR Oral Capsule, Drug Approval Package , posted 2/13/02

Prevacid (lansoprazole) Delayed-Release Oral Suspension, Drug Approval
Package , posted 2/13/02

Augmintin ES (Amoxicillin/Clavulanate Potassium) Powder Oral Suspension,
Drug Approval Package , posted 2/12/02

Clarinex (Deloratadine) Tablets, Drug Approval Package , posted 2/12/02

ORTHO EVRA (Norelgestromin/Ethinyl Estradiol) Transdermal System, Drug
Approval Package , posted 2/12/02

Approved Drug Products with Therapeutic Equivalence: Query (2/12/2002)
http://www.fda.gov/cder/ob/default.htm

Drug Shortages
http://www.fda.gov/cder/drug/shortages/default.htm
Cytovene (ganciclovir) 2/12/2002
Furosemide injection 2/12/2002


Drug Information (Updated 2/8/2002)

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 2/8/2002)
http://www.fda.gov/cder/approval/index.htm

Actos (pioglitazone HCl) Tablets, Takeda, posted 2/8/02

Alkeran (mephalan) Tablets 2 mg, and Alkeran (mephalan hydrochloride)
Injection, SmithKlineBeecham Corporation d/b/a GlaxoSmithKline, posted
2/8/02

Carteolol Hydrochloride Ophthalmic Solution USP, Novex Pharma, posted 2/8/02

Ciprofloxacin Ophthalmic Solution USP, Novex Pharma, Tentatively Approved,
posted 2/8/02

Clozaril (clozapine) Tablets, Novartis Pharmaceuticals Corporation, posted
2/8/02

Doxil (doxorubicin HCl liposome) Injection, ALZA Corporation, posted 2/8/02

Fluoxetine Hydrochloride Oral Solution, Apotex Corp., posted 2/8/02

Fluoxetine Hydrochloride Tablets, Barr laboratories, posted 2/8/02

Fluoxetine Oral Solution USP, Alpharma, posted 2/8/02

Fluoxetine Capsules USP, IVAX Pharmaceuticals, Inc., posted 2/8/02

Glucophage and Glucophage XR, Bristol-Myers Squibb, posted 2/8/02

Indomethacin Extended-release Capsules USP, Able Labs, posted 2/8/02

Methylphenidate Hydrochloride Tablets USP, Purepac Pharmaceutical Co.,
posted 2/8/02

Pitocin (oxytocin) Injection USP, Parkedale Pharmaceuticals, Inc., posted
2/8/02

Promethazine Hydrochloride Suppositories USP, G & W Laboratories, Inc,
posted 2/8/02

Propafenone Hydrochloride Tablets, , posted 2/8/02

Glyburide Tablets USP (Micronized), Al-Hikma Pharmaceuticals, Tentatively
Approved, posted 2/8/02

Lisinopril Tablets USP, Watson Labs, Tentatively Approved, posted 2/8/02

Quinapril Hydrochloride Tablets, Teva Pharmaceuticals, Tentatively Approved,
posted 2/8/02

Ritalin and Ritalin-SR, Novartis Pharmaceuticals Corporation, posted 2/8/02

Serzone (nefazodone hydrochloride) Tablets, Bristol-Myers Squibb Company ,
posted 2/8/02

Stadol NS (butorphanol tartrate) Nasal Spray, Bristol-Myers Squibb Company,
posted 2/8/02

Zantac®(ranitidine hydrochloride) Tablets, Syrup, USP, GELdose® Capsules &
EFFERdose® Tablets and Granules, GlaxoSmithKline, posted 2/8/02

Zantac®(ranitidine hydrochloride) Injection & Premixed Injection,
GlaxoSmithKline, posted 2/8/02

Androderm® (testosterone transdermal system), Theratech, Inc., posted 2/7/02

Caverject (Alprostadil for Injection) Sterile Powder, Pharmacia & Upjohn
Co., posted 2/7/02

Infant's Motrin, McNeil Consumer & Specialty Pharmaceuticals, posted 2/7/02

NORPLANT SYSTEM (levonorgestrel implant), Wyeth Ayerst Laboratories, Inc.,
posted 2/7/02

Oxycontin (oxycodone HCl) Controlled Release Tablets, Purdue Pharma L. P.,
posted 2/7/02

Trelstar(tm) Depot (triptorelin pamoate for injectable suspension),
Pharmacia & Upjohn Company, posted 2/7/02

Alupent (Metaproterenol Sulfate) Inhalation Solution, Boehringer Ingelheim
Pharmaceuticals, Inc., posted 2/5/02

Cafcit (caffeine citrate) Injection & Oral Solution, O.P.R. Development,
L.P., posted 2/5/02

Cardura (doxazosin mesylate) Tablets, Pfizer , posted 2/5/02

Claforan (cefotaxime sodium) Injection and Sterile Solution, Aventis
Pharmaceuticals, posted 2/5/02

Cutivate (fluticasone propionate) Ointment, GlaxoSmithKline, posted 2/5/02

Diovan HCT (valsartan/hydrochlorothiazide) Tablets, Novartis Pharmaceuticals
Corp., posted 2/5/02

Dipentum (olsalazine sodium) Capsules, Pharmacia & Upjohn Company , posted
2/5/02

Emcyt (estramustine phosphate sodium) Capsules, Pharmacia and Upjohn ,
posted 2/5/02

Glofil-125, Questcor Pharmaceuticals, Inc. , posted 2/5/02

Kaletra (lopinavir/ritonavir) Capsules & Oral Solution, Abbott Laboratories,
posted 2/5/02

Lidocaine Hydrochloride in 5% Dextrose Injection in Viaflex® Plastic, Baxter
Healthcare Corp, posted 2/5/02

Nix Creme Rinse (1% permethrin shampoo), Pfizer Incorporated, posted 2/5/02

Orfadin (Nitisinone) Capsules, Swedish Orphan, AB (R&R Registration is the
U.S. Agent, posted 2/5/02

Prandin (repaglinide) Tablets, Novo Nordisk Pharmaceuticals, Inc., posted
2/5/02

ProStep (nicotine transdermal system), Elan Pharmaceutical Research
Corporation, posted 2/5/02

TEMODAR (Temozolomide) Capsules, Schering Corporation, posted 2/5/02


Drug Information (Updated 2/1/2002)
-------------------------------------------------
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 2/1/2002)
http://www.fda.gov/cder/approval/index.htm

Mometasone Furoate Ointment USP, Clay-Park Labs, Inc., Tentative Approval,
posted 2/1/02

Fluoxetine Capsules USP,Ranbaxy Laboratories Limited, Inc., posted 2/1/02

Gleevec (imatinib mesylate) capsules, Novartis Pharmaceuticals Corporation,
posted 2/1/02

Sustiva (Efavirenz) Tablets, Bristol-Myers Squibb Pharma Company, posted
2/1/02

Clindamycin Phosphate Lotion, Altana, Inc., posted 1/31/02

Fluoxetine Capsules USP, Dr. Reddy's Laboratories Ltd., posted 1/31/02

Fluoxetine Capsules USP, Barr Laboratories, Inc., posted 1/31/02

Fluoxetine Capsules USP, Ganes Chemicals for Siegfried, Ltd., posted 1/31/02

Fluoxetine Capsules USP, Mylan Pharmaceuticals, posted 1/31/02

Xopenex (levalbuterol HCl) Inhalation Solution, Sepracor Inc., posted
1/31/02

Dextroamphetamine Sulfate Tablets USP, Mallinckrodt Inc., posted 1/30/02

Fluoxetine Capsules USP, Chelsea Laboratories, Inc., posted 1/30/02

Fluoxetine Hydrochloride Tablets, Teva Pharmaceuticals, posted 1/30/02

Fluoxetine Capsules USP, TEVA Pharmaceuticals USA, posted 1/30/02

Fluoxetine Capsules USP, Mallinckrodt, Inc., posted 1/30/02

Fluoxetine Capsules USP, Alphapharm Pty. Ltd., posted 1/30/02

Fluoxetine Oral Solution, Mallinckrodt, Inc., posted 1/30/02

Fluoxetine Capsules USP, Mutual Pharmaceutical Co. Inc., posted 1/30/02

Fluoxetine Oral Solution, Pharmaceutical Associates, posted 1/30/02

Fluoxetine Capsules USP, Geneva, posted 1/30/02

Fluoxetine Capsules USP, Eon Labs Manufacturing, Inc., posted 1/30/02

Fluoxetine Capsules USP, Sidmark Laboratories, Inc., posted 1/30/02

Fluoxetine Hydrochloride Tablets, Eon Labs Manufacturing, Inc., posted
1/30/02

Fluoxetine Capsules USP, Carlsbad Technology, Inc., posted 1/30/02

Fluoxetine Capsules USP, Dr. Reddy's Laboratories Limited, posted 1/30/02

Invanz (Ertapenem Sodium), Merck & Co., posted 1/29/02

Metformin Hydrochloride Tablets, Caraco Pharmaceutical Laboaratories, Ltd.,
posted 1/30/02

Metformin Hydrochloride Tablets, Alphapharm Pty Ltd., posted 1/30/02

Metformin Hydrochloride Tablets, Barr Laboratories Inc., posted 1/28/02

Metformin Hydrochloride Tablets, Eon Labs, posted 1/28/02

Metformin Hydrochloride Tablets, Andrx Pharmaceuticals, posted 1/28/02

Metformin Hydrochloride Tablets, Geneva Pharmaceuticals, posted 1/28/02

Podofilox Topical Solution, Paddock Laboratories, Inc., posted 1/30/02


DRUG APPROVAL PACKAGES

Arixtra (Fondaparinux Sodium) Injection, Drug Approval Package, posted
2/1/02

Tracleer (Bosentan) Tablets, Drug Approval Package, posted 2/1/02

Yasmin 28 (drosperinone 3 mg/ethinyl estradiol 0.030 mg) Tablets, Drug
Approval Package, posted 2/1/02

Avelox IV (Moxifloxacin Hydrochloride in Sodium Chloride) Injection, Drug
Approval Package, posted 1/31/02

Cefuroxime for Injection USP & Dextrose Injection USP, Drug Approval
Package, posted 1/30/02

Invanz (Ertapenem Sodium), Drug Approval Package, posted 1/28/02

Zyvox (linezolid) Tablets, I.V., & Oral Suspension, Drug Approval Package,
posted 1/29/02

Entocort EC (Budesonide) Capsules, Drug Approval Package, posted 1/28/02

Mifepristone (Mifeprex) Index of Redacted Documents (1/30/2002)
http://www.fda.gov/cder/archives/mifepristone/default.htm

Over-the-Counter (OTC) Drug Review [Text]
http://www.fda.gov/cder/otc/ua03de01.htm
or [PDF] (Issued 12/3/2001, Posted 1/29/2002)
http://www.fda.gov/cder/otc/ua03de01.pdf

 

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Drug Information  (Updated 12/28/2001)
-------------------------------------------------
FDA Drug Approvals List (12/28/2001)
http://www.fda.gov/cder/da/da.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 12/28/2001)
http://www.fda.gov/cder/approval/index.htm

Ketamine Hydrochloride Injection USP, Bioniche Pharmra (Canada) Ltd., posted
12/28/01

Ciprofloxacin Tablets USP, Teva Pharmaceuticals, USA, Tentatively Approved,
posted 12/27/01

Metformin Hydrochloride Tablets, Goldline Laboratories, Inc., Approvable,
posted 12/27/01

Metformin Hydrochloride Tablets, Caraco Pharmaceutical Laboratories, Inc.,
Approvable, posted 12/27/01


DRUG APPROVAL PACKAGES

Clobetasol Propionate Topical Solution USP, Drug Approval Package, posted
12/28/01

Ibuprofen Oral Suspension USP, Drug Approval Package, posted 12/28/01

Loperamide Hydrochloride Tablets USP, Drug Approval Package, posted 12/28/01

Nabumetone Tablets, Drug Approval Package, posted 12/28/01

Sotalol Hydrochloride Tablets, Drug Approval Package, posted 12/28/01

Cromolyn Sodium Inhalation Solution USP, Drug Approval Package, posted
12/26/01

Furosemide Injection USP, Drug Approval Package, posted 12/27/01

Ketoconazole Tablets, Drug Approval Package, posted 12/26/01

Pamidronate Disodium Injection, Drug Approval Package, posted 12/26/01

Tretinoin Topicals Solution USP, Drug Approval Package, posted 12/26/01


Drug Information  (Updated 12/18/2001)
-------------------------------------------------
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 12/18/2001)
http://www.fda.gov/cder/approval/index.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 12/21/2001)
http://www.fda.gov/cder/approval/index.htm

Clarinex (Deloratadine) Tablets, Schering Corporation, posted 12/21/01

Famotidine Tablets USP, Genpharm Inc., posted 12/21/01

Methylphenidate Hydrochloride Extended-release Tablets USP, Purepac
Pharmaceutical Co., posted 12/21/01

Naproxen Tablets, Interpharm, Inc., posted 12/21/01

NovoLog (insulin aspart [rDNA origin]) Injection, Novo Nordisk, posted
12/21/01

Permethrin Lotion, Clay-Park Labs, Inc., posted 12/21/01


Midazolam Hydrochloride Syrup, Ranbaxy Laboratories Ltd., Tentatively
Approved, posted 12/21/01

Loratadine Tablets, Ranbaxy Laboratories Ltd., Tentatively Approved, posted
12/21/01

Lisinopril Tablets USP, Zenith Goldline Pharmaceuticals, Inc., Tentatively
Approved, posted 12/21/01

Lisinopril Tablets USP, Lek Pharmaceutical and Chemical Company, Tentatively
Approved, posted 12/21/01

Advicor (Niacin & Lovastatin) Tablets, Kos Pharmaceuticals, Inc., posted
12/18/01

Cyclosporine Oral Solution USP (Modified), Sidmak Laboratories, Inc., posted
12/18/01

Famotidine Injection, Abbott Laboratories, posted 12/18/01

Lovastatin Tablets USP, Geneva Pharmaceuticals, posted 12/18/01

Lovastatin Tablets USP, Purepac Pharmaceutical Co., posted 12/18/01

Lovastatin Tablets USP, Eon Labs Manufacturing, Inc., posted 12/18/01

Lovastatin Tablets USP, Genpharm Inc., posted 12/18/01

Lovastatin Tablets USP, Mylan Pharmaceuticals, Inc., posted 12/18/01

Lovastatin Tablets USP, TEVA Pharmaceuticals, USA, posted 12/18/01


DRUG APPROVAL PACKAGES

Ticlopidine Hydrochloride Tablets, Drug Approval Package, posted 12/20/01

Paclitaxel Injection, Drug Approval Package, posted 12/20/01

Agenerase (amprenavir) Capsules and Oral Solution, Drug Approval Package,
posted 12/18/01

Albuterol Sulfate Inhalation Solution, Drug Approval Package, posted
12/18/01

Diflorasone Diacetate Ointment USP, Drug Approval Package, posted 12/18/01

Levoxyl (levothyroxine sodium) Tablets, Drug Approval Package, posted
12/18/01

Miconazole Nitrate Vaginal Suppositories USP & Miconazole Nitrate Cream USP,
Drug Approval Package, posted 12/18/01

Nolvadex (tamoxifen citrate) Tablets, Drug Approval Package, posted 12/18/01

Reminyl (galantamine hydrobromide) Tablets, Drug Approval Package, posted
12/18/01

Sotalol Hydrochloride Tablets, Drug Approval Package, posted 12/18/01

Ticlid (Ticlopidine Hydrochloride) Tablets, Drug Approval Package, posted
12/18/01

Aviane-21 and Aviane-28 Tablets, Drug Approval Package, posted 12/17/01

Benzedrine (Amphetamine Sulfate) Tablets, Drug Approval Package, posted
12/17/01

Cromolyn Sodium Nasal Solution USP, Drug Approval Package, posted 12/17/01

Famotidine Injection (ANDA 75-684), Drug Approval Package, posted 12/17/01

Famotidine Injection (ANDA 75-669), Drug Approval Package, posted 12/17/01

Levocarnitine Injection USP, Drug Approval Package, posted 12/17/01

Naproxen Delayed-release Tablets, Drug Approval Package, posted 12/17/01
Sotalol Hydrochloride Tablets, Drug Approval Package, posted 12/17/01

Timolol Maleate Ophthalmic Solution USP, Drug Approval Package, posted
12/17/01

Thiotepa for Injection, Drug Approval Package, posted 12/17/01

Approved Drug Products with Therapeutic Equivalence: Query (12/21/2001)
http://www.fda.gov/cder/ob/default.htm

Approved Drug Products with Therapeutic Equivalence Evaluations-21st Edition
(Cumulative Supplement-9) (12/19/2001)
http://www.fda.gov/cder/orange/supplement/cspreface.htm
[Information and Data Files] (12/19/2001)
http://www.fda.gov/cder/orange/obreadme.htm

Approved Drug Products with Therapeutic Equivalence Evaluations Monthly
Additions and Deletions (September) (12/19/2001)
http://www.fda.gov/cder/rxotcdpl/pdpl_200109.htm

Commentary on Non-Labeled Dosing of Oral Amoxicillin in Adults and
Pediatrics for Post-Exposure Inhalational Anthrax (12/17/2001)
http://www.fda.gov/cder/drugprepare/amox-anthrax.htm

Safety of Long Term Therapy with Penicillin and Penicillin Derivatives
(12/17/2001)
http://www.fda.gov/cder/drugprepare/penlongsafety.htm


Drug Information  (Updated 12/14/2001)
-------------------------------------------------
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 12/14/2001)
http://www.fda.gov/cder/approval/index.htm

Cromolyn Sodium Nasal Solution USP L. Perrigo Company, posted 12/14/01

Diclofenac Sodium Extended-release Tablets, Mylan Pharmaceuticals Inc.,
posted 12/14/01

Elidel (pimecrolimus) Cream, Novartis Pharmaceuticals Corporation, posted
12/14/01

Famotidine Tablets, Mutual Pharmaceutical Company, Inc., posted 12/14/01

Ibuprofen Tablets USP, BASF Corporation, posted 12/14/01

Tigan Capsules King Pharmaceuticals, Inc, posted 12/14/01

Arixtra (Fondaparinux Sodium) Injection, Fonda BV, posted 12/11/01

Lotrimin Ultra Butenafine Hydrochloride Cream, Schering-Plough HealthCare,
posted 12/11/01


DRUG APPROVAL PACKAGES

Mesna Injection, Drug Approval Package, posted 12/14/01

Levocarnitine Injection, Drug Approval Package, posted 12/14/01

Progesterone Injection, Drug Approval Package, posted 12/14/01

Estrostep (Norethindrone Acetate & Ethinyl Estradiol) Tablets, Drug Approval
Package, posted 12/12/01

Imodium Advanced (Loperamide HCI and Simethicone) Caplet, Drug Approval
Package, posted 12/12/01

Kytril (granisetron) Oral Solution, Drug Approval Package, posted 12/12/01

Tazorac (tazarotene) Cream, Drug Approval Package, posted 12/12/01

Visudyne (verteporfin) Injection suppl 1, Drug Approval Package, posted
12/12/01

Axert (almotriptan) Tablets, Drug Approval Package, posted 12/11/01

Genotropin (somatropin [rDNA origin]) Injection), Drug Approval Package,
posted 12/11/01

Lac-Hydrin Cream, Drug Approval Package, posted 12/11/01

Orgaran (Danaparoid Sodium) Injection, Drug Approval Package, posted
12/11/01

Pravachol (pravastatin) Tablets, Drug Approval Package, posted 12/11/01

Priftin (rifapentine) Tablets, Drug Approval Package, posted 12/11/01

Visicol Tablets, Drug Approval Package, posted 12/11/01

Visudyne (verteporfin) Injection, Drug Approval Package, posted 12/11/01

Shared Exclusivity for Omeprazole (12/14/2001)
http://www.fda.gov/cder/ogd/shared_exclusivity.htm

Frequently Asked Questions about Importing Beef Insulin for Personal Use
(12/13/2001)
http://www.fda.gov/cder/drug/beefinsulin/default.htm

Drug Shortages
http://www.fda.gov/cder/drug/shortages/default.htm
Cortrosyn (cosyntropin) Injection Updated 12/11/2001
Phenobarbital injection Updated 12/11/2001


Drug Information  (Updated 12/07/2001)
-------------------------------------------------
Participation of Racial/Ethnic Groups in Clinical Trials and Race-Related
Labeling: A Review of New Molecular Entities Approved 1995-1999 (12/7/2001)

http://www.fda.gov/cder/reports/race_ethnicity/race_ethnicity_report.htm

FDA Drug Approvals List (12/7/2001)
http://www.fda.gov/cder/da/da.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 12/7/2001)
http://www.fda.gov/cder/approval/index.htm

Extended Phenytoin Sodium Capsules USP, Mylan Pharmaceuticals Inc., posted
12/6/01

Ofloxacin Tablets, Par Pharmaceutical, Inc., Tentatively Approved, posted
12/6/01


DRUG APPROVAL PACKAGES
Spectracef (Cefditoren Pivoxil) Tablets, Drug Approval Package, posted
12/7/01

Benzedrine (Amphetamine Sulate) Tablets, Drug Approval Package, posted
12/6/01

Enalaprilat Injection, Drug Approval Package, posted 12/6/01

Isosorbride Mononitrate Extended-release Tablets, Drug Approval Package,
posted 12/6/01

Ketoconazole Cream, Drug Approval Package, posted 12/6/01

Naltrexone Hydrochloride Tablets USP, Drug Approval Package, posted 12/6/01


Vincristine Sulfate Injection, Drug Approval Package, posted 12/6/01

Bupropion Hydrochloride Tablets, Drug Approval Package, posted 12/5/01

Etoposide Capsules USP, Drug Approval Package, posted 12/5/01

Methylin ER Tablets (Methylphenidate Hydrochloride Extended-release Tablets
USP), Drug Approval Package, posted 12/5/01

Oxaprozin Tablets, Drug Approval Package, posted 12/5/01

Sotalol Hydrochloride Tablets, Drug Approval Package, posted 12/5/01

Ursodiol Capsules USP, Drug Approval Package, posted 12/5/01

Avapro (irbesartan) Tablets, Drug Approval Package, posted 12/4/01

Tiazac/Diltiazem Hydrochloride Capsules, Drug Approval Package, posted
12/4/01

Baycol (cerivastatin) Tablets suppl 6, Drug Approval Package, posted 12/3/01


Baycol (cerivastatin) Tablets suppl 14, Drug Approval Package, posted
12/3/01

Baycol (cerivastatin) Tablets suppl 18, Drug Approval Package, posted
12/3/01

Baycol (cerivastatin) Tablets suppl 19, Drug Approval Package, posted
12/3/01

Hyzaar (losartan potassium/hydrochlorothiazide) Tablets suppl 6, Drug
Approval Package, posted 12/3/01

Hyzaar (losartan potassium/hydrochlorothiazide) Tablets suppl 8, Drug
Approval Package, posted 12/3/01

Hyzaar (losartan potassium/hydrochlorothiazide) Tablets suppl 10, Drug
Approval Package, posted 12/3/01

 

Top

Drug Information  (Updated 11/30/2001)
-------------------------------------------------
FDA Drug Approvals List (11/30/2001)
http://www.fda.gov/cder/da/da.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 11/30/2001)
http://www.fda.gov/cder/approval/index.htm

Avelox IV (Moxifloxacin Hydrochloride in Sodium Chloride) Injection, Bayer
Corporation, posted 11/30/01

Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules USP, Anabolic,
Inc., posted 11/30/01

Cryselle (Norgestrel & Ethinyl Estradiol) Tablets USP, Duramed
Pharmaceuticals, Inc. , posted 11/30/01

Etodolac Extended-Release Tablets, Andrx, posted 11/30/01

Leuprolide Acetate Injection, Genzyme Corporation, posted 11/30/01

Propafenone Tablets, Mutual Pharmaceutical Co., posted 11/29/01

Pamidronate Disodium Injection, Aesgen, Inc., Tentatively Approved, posted
11/29/01

Desogestrel & Ethinyl Estradiol Tablets, Duramed Pharmaceuticals,
Tentatively Approved, posted 11/29/01

Famotidine Injection, Abbott Laboratories, posted 11/28/01

Famotidine Tablets USP, Danbury Pharmacal, Inc., posted 11/28/01

Acetaminophen, Aspirin & Caffeine Tablets, L. Perrigo Company, posted
11/26/01

Ethambutol Hydrochloride Tablets USP, Barr Laboartories, Inc., posted
11/26/01

Percocet (Oxycodone Hydrochloride and Acetaminophen) Tablets USP, Endo
Pharmaceuticals, Inc., posted 11/26/01

Ofloxacin Tablets, Teva Pharmaceuticals, Tentatively Approved, posted
11/26/01


DRUG APPROVAL PACKAGES
Baycol (cerivastatin) Tablets, Drug Approval Package, posted 11/29/01

Baycol (cerivastatin) Tablets supp 2, Drug Approval Package, posted 11/28/01


Baycol (cerivastatin) Tablets supp 3, Drug Approval Package, posted 11/28/01


Epivir-HBV (lamivudine) Tablets and Oral Solution, Drug Approval Package,
posted 11/26/01

Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets, Drug
Approval Package, posted 11/28/01

Warning and Untitled Letters-2001 (11/29/2001)
http://www.fda.gov/cder/warn/warn2001.htm


Drug Information  (Updated 11/23/2001)
-------------------------------------------------
FDA Drug Approvals List (11/23/2001)
http://www.fda.gov/cder/da/da.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 11/23/2001)
http://www.fda.gov/cder/approval/index.htm

Bextra (Valdecoxib), G.D. Searle & Co., posted 11/23/01

Daunorubicin Hydrochloride Injection, SuperGen, Inc., posted 11/23/01

Diltiazem Hydrochloride Injection, International Medication Systems, Ltd,
posted 11/23/01

Dutasteride, GlaxoSmithKline, posted 11/23/01

Ibuprofen Tablets USP, Dr. Reddy's Laboratories Ltd., posted 11/23/01

Omeprazole delayed-release Capsules, Andrx Pharmaceuticals, Inc., posted
11/23/01

ORTHO EVRA (Norelgestromin/Ethinyl Estradiol) Transdermal System, R.W.
Johnson Pharmaceutical Research Institue, posted 11/23/01

Thallous Chloride TI-201 Injection USP, Mount Sinai Medical Center, posted
11/23/01

Tioconazole Vaginal Ointment, L. Perrigo Co., posted 11/23/01

Tracleer (Bosentan) Tablets, Actelion, Ltd., posted 11/23/01

DRUG APPROVAL PACKAGES
BIAXIN XL Filmtab (clarithromycin extended-release), Drug Approval Package,
posted 11/23/01

Biaxin (clarithromycin) Filmtab, Drug Approval Package, posted 11/23/01

AmBisome (amphotericin B) Liposome Injection Suppl. 1, Drug Approval
Package, posted 11/20/01

AmBisome (amphotericin B) Liposome Injection Supp. 2, Drug Approval Package,
posted 11/20/01

Avandia (rosiglitazone) Tablets, Drug Approval Package, posted 11/20/01

Avandia (rosiglitazone maleate) Tablets, Drug Approval Package, posted
11/20/01

Diovan (Valsartan) Tablets, Drug Approval Package, posted 11/20/01

Mentax (Butenafine HCI) Cream, Drug Approval Package, posted 11/20/01

Amoxicillin (Amoxil, Larotid, Trimox, Wymox) Use by Pregnant and Lactating
Women (11/20/2001)
http://www.fda.gov/cder/drugprepare/amoxicillinpreg.htm

Approved Drug Products with Therapeutic Equivalence Evaluations-21st Edition
(Cumulative Supplement-8) (11/20/2001)
http://www.fda.gov/cder/orange/supplement/cspreface.htm
[Information and Data Files] (11/20/2001)
http://www.fda.gov/cder/orange/obreadme.htm

Approved Drug Products with Therapeutic Equivalence: Query (11/20/2001)
http://www.fda.gov/cder/ob/default.htm

Approved Drug Products with Therapeutic Equivalence Evaluations Monthly
Additions and Deletions (August) (11/20/2001)
http://www.fda.gov/cder/rxotcdpl/pdpl_200108.htm

Yasmin,
http://www.fda.gov/cder/consumerinfo/druginfo/yasmin.htm
Zyvox,
http://www.fda.gov/cder/consumerinfo/druginfo/ZYVOX.HTM
and Celebrex (11/19/2001)
http://www.fda.gov/cder/consumerinfo/druginfo/celebrex.htm


Drug Information  (Updated 11/08/2001)
-------------------------------------------------
Generic Drug Approvals List (11/8/2001)
http://www.fda.gov/cder/ogd/approvals/default.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 11/9/2001)
http://www.fda.gov/cder/approval/index.htm

Milrinone Lactate Injection, Faulding Pharmaceutical Company, Tentatively
Approved, posted 11/8/01

Zithromax (Azithromycin) Capsules, Single Dose Packet & Tablets, Drug
Approval Package, posted 11/9/01

Lodine XL (etodolac) Tablets, Drug Approval Package, posted 11/8/01

Zometa, Drug Approval Package, posted 11/8/01

NuvaRing, Drug Approval Package, posted 11/8/01


Drug Information  (Updated 11/01/2001)
-------------------------------------------------
Doxycyline and Penicillin G Procain for Inhalational Anthrax
(Post-Exposure) (11/1/2001)
http://www.fda.gov/cder/drug/infopage/penG_doxy/default.htm

Drug Shortages
http://www.fda.gov/cder/drug/shortages/default.htm
MVI-Pediatric (Updated 11/1/2001)

Generic Drug Approvals List (11/2/2001)
http://www.fda.gov/cder/ogd/approvals/default.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 11/2/2001)
http://www.fda.gov/cder/approval/index.htm

Accutane (isotretinoin) Capsules, posted 11/2/01

Rimantadine Hydrochloride Tablets, Corepharma, LLC, posted 11/2/01

NovoLog Mix 70/30 Injection,Novo Nordisk, posted 11/2/01

VIREAD (tenofovir disoproxil fumarate), Gilead Sciences, Inc, posted
11/2/01

Coreg (Carvedilol) Tablets, GlaxoSmithKline, posted 11/1/01

Ibuprofen Tablets USP, Dr. Reddy's Laboratories Ltd., posted 11/1/01

Milrinone Lactate in 5% Dextrose Injection, Baxter Healthcare
Corporation, Tentatively Approved, posted 11/1/01


Definity (perflutren Lipid Microsphere) Injectable Suspension, DuPont
Pharmaceuticals Company, Drug Approval Package, posted 11/1/01

CellCept (mycophenolate mofetil hydrochloride) Intravenous / Oral
Suspension / Capsules / Tablets, Drug Approval Package, posted 11/1/01

CellCept (mycophenolate mofetil hydrochloride) Oral Suspension /
Capsules / Tablets, Drug Approval Package, posted 11/1/01


Cipro (Ciprofloxacin): Use by Pregnant and Lactating Women (10/31/2001)
http://www.fda.gov/cder/drug/infopage/cipro/cipropreg.htm

Doxycycline: Questions and Answers for Consumers (10/31/2001)
http://www.fda.gov/cder/drug/infopage/penG_doxy/QA_doxy.htm

Doxycycline (Vibramycin, Monodox, Doryx, Doxy, Atridox, Periodox,
Vibra-Tabs): Use by Pregnant and Lactating Women (10/31/2001)
http://www.fda.gov/cder/drug/infopage/penG_doxy/doxypreg.htm

Drug Preparedness and Response to Bioterrorism (10/31/2001)
http://www.fda.gov/cder/drugprepare/default.htm

FDA Drug Approvals List (10/29/2001)
http://www.fda.gov/cder/da/da.htm

List of Published Literature Relied on in Issuing the Federal Register
Notice on Doxycycline and Penicillin G Procaine Administration for
Inhalational Anthrax (Post-Exposure) (10/29/2001)
http://www.fda.gov/cder/drug/infopage/penG_doxy/bibliolist.htm


Drug Information  (Updated 10/26/2001)
-------------------------------------------------
Drug Master Files (10/26/2001)
http://www.fda.gov/cder/dmf/index.htm

Warning and Untitled Letters-2001 (10/26/2001)
http://www.fda.gov/cder/warn/warn2001.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 10/23/2001)
http://www.fda.gov/cder/approval/index.htm

Butorphanol Tartrate Injection USP, Apotex Corp., posted 10/23/01

Celebrex Capsules, G. D. Searle & Co., posted 10/23/01

Dacarbazine for Injection USP, Faulding Pharmaceutical Co., posted
10/23/01

Prednisolone Syrup USP, KV Pharmaceutical Company, posted 10/23/01

Protonix I. V. (pantoprazole sodium) Injection, Wyeth-Ayerst
Laboratories, posted 10/23/01


Sporanox (itraconazole) Injection & Oral Solution, Janssen Research
Foundation, Drug Approval Package, posted 10/26/01


Drug Information  (Updated 10/17/2001)
-------------------------------------------------
Approved Drug Products with Therapeutic Equivalence Evaluations-21st
Edition (Cumulative Supplement-7) (10/17/2001)
http://www.fda.gov/cder/orange/supplement/cspreface.htm
[Information and Data Files] (10/17/2001)
http://www.fda.gov/cder/orange/obreadme.htm

Approved Drug Products with Therapeutic Equivalence: Query (10/19/2001)
http://www.fda.gov/cder/ob/default.htm

Drug Firm Annual Registration Status (10/19/2001)
http://www.fda.gov/cder/dfars/default.htm

Drug Shortages
http://www.fda.gov/cder/drug/shortages/default.htm
MVI-Pediatric (10/17/2001)

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 10/15-10/19/2001)
http://www.fda.gov/cder/approval/index.htm

Adderall XR Oral Capsule, Shire Laboratories, posted 10/18/01
Bleomycin for Injection USP, Bedford Laboratories, posted 10/18/01
Fluoxetine Capsules USP, Sidmark Laboratories, Inc., Tentatively Approved,
posted 10/18/01
Lisinopril and Hydrochlorothiazide Tablets USP, Geneva Pharmaceuticals,
Tentatively Approved, posted 10/18/01
Milrinone Lactate Injection, American Pharmaceutical Partners, Inc.,
Tentatively Approved, posted 10/18/01
Gleevec (imatinib mesylate) capsules, Novartis Pharmaceuticals Corporation,
Drug Approval Package, posted 10/17/01
Natrecor (nesiritide) for injection, Scios, Inc., Drug Approval Package,
posted 10/17/01
Atropine Sulfate Injection, USP, Abbot Laboratories, Drug Approval Package,
posted 10/17/01
Avelox (moxifloxacin HCl) Tablet, Bayer Corporation, Drug Approval Package,
posted 10/17/01
Cipro (Ciprofloxacin Hydrochloride) Tablets, IV Solution, IV in 5% Dextrose,
IV in 0.9% Saline, & Oral Suspension, Bayer Corporation, Pharmaceutical
Division, Drug Approval Package, posted 10/16/01
Cancidas, Merck Research Laboratories, Drug Approval Package, posted
10/16/01
Enalapril Maleate and Hydrochlorothiazide Tablets USP, Dr. Reddy's
Laboratories Limited, posted 10/15/01
Fluvoxamine Maleate Tablets, Genpharm Inc., posted 10/15/01
Ipratropium Bromide Inhalation Solution, Bausch & Lomb Pharmaceuticals,
Inc., posted 10/15/01
Sotalol Hydrochloride Tablets, Mutual Pharmaceutical Company, posted
10/15/01
Tequin (Gatifloxacin) Tablets & Injection, Bristol-Myers Squibb, posted
10/15/01
Famotidine Tablets USP, Genpharm Inc., Tentatively Approved, posted 10/15/01

 

Top

Drug Information  (Updated 10/12/2001)
-------------------------------------------------
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 10/12/2001)
http://www.fda.gov/cder/approval/index.htm

Calctriol Capsules, TEVA Pharmaceuticals USA, posted 10/12/01

Derma-Smoothe/FS (Fluocinolone Acetonide Topical Oil), Hill
Dermaceuticals, Inc., posted 10/12/01

Gentamicin Sulfate Ophthalmic Solution USP, Akorn New Jersey, Inc.,
posted 10/12/01

Lisinopril Tablets USP, Ranbaxy Laboratories, Tentatively Approved,
posted 10/12/01


Helicosol (C-13 Urea) lyophilized powder, Drug Approval Package, posted
10/12/01

BIAXIN XL Tablets (clarithromycin extended-release), Drug Approval
Package, posted 10/12/01

Skin Exposure Reduction Paste (SERPACWA), Drug Approval Package, posted
10/12/01

Rapamune (sirolimus) Tablets, Drug Approval Package, posted 10/12/01

Exelon (rivastigmine tartrate) Capsules, Drug Approval Package, posted
10/12/01

Ultracet (Tramadol & Acetaminophen) Tablets, Drug Approval Package,
posted 10/12/01

Flyer on FDA Public Health Advisory: Medical Gas Mix-Ups Can Cause Death
and Serious Injury
http://www.fda.gov/cder/Offices/OTCOM/DPA/PSAs/medflyer.pdf
Optional format: HTML (10/12/2001)
http://www.fda.gov/cder/consumerinfo/medgas.htm

The Generic Pharmaceutical Association's 2001 Fall Techinical Workshop
in conjunction with the FDA will be held October 28-30, 2001
(10/12/2001)
http://www.fda.gov/cder/ogd/index.htm#New

Safety of Sodium Phosphates Oral Solution (10/12/2001)
http://www.fda.gov/cder/drug/safety/sodiumphospate.htm

National Drug Code Directory Searchable Database (10/9/2001)
http://internet-dev/cder/ndc/database/default.htm

Warning and Untitled Letters-2001 (10/9/2001)
http://www.fda.gov/cder/warn/warn2001.htm


Drug Information  (Updated 10/05/2001)
-------------------------------------------------
FDA Drug Approvals List (10/5/2001)
http://www.fda.gov/cder/da/da.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 10/5/2001)
http://www.fda.gov/cder/approval/index.htm

Diprosone (Betamethasone Dipropionate) Cream, Schering Corporation,
posted 10/5/01

Diprosone (Betamethasone Dipropionate) Ointment, Schering Corporation,
posted 10/5/01

Diprosone (Betamethasone Dipropionate) Lotion, Schering Corporation,
posted 10/5/01

Diprosone AF (Betamethasone Dipropionate) Cream, Schering Corporation,
posted 10/5/01

Oxaprozin Tablets, Purepac Pharmaceutical Co., posted 10/5/01

Entocort EC (Budesonide) Capsules, AstraZeneca LP, posted 10/3/01

Lotrisone (clotrimazole and betamethasone diproprionate) Cream, Schering
Corporation, posted 10/3/01

Minoxidil Topical Solution USP (for Men) 5% Solution, Novex Pharma,
posted 10/3/01

NuvaRing (Etonogestrel/Ethinyl Estradiol Vaginal Ring), Organon, Inc.,
posted 10/3/01


http://www.fda.gov/cder/foi/nda/index97.htm
Zoladex Depot, Drug Approval Package, posted 10/3/01

National Drug Code (NDC) Directory (Updated 10/2/2001).
http://www.fda.gov/cder/ndc/index.htm

 


Drug Information  (Updated 9/28/2001)
-------------------------------------------------
FDA Drug Approvals List (9/28/2001)
http://www.fda.gov/cder/da/da.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 9/28/2001)
http://www.fda.gov/cder/approval/index.htm

Ipratropium Bromide Inhalation Solution, Nephron Pharmaceuticals
Corporation, posted 9/28/01

Lithium Carbonate Capsules USP, Able Laboratories, Inc., posted 9/28/01

Fluoxetine Oral Solution, Mallinckrodt, Inc., Tentatively Approved,
posted 9/28/01

Nizatidine Capsules USP, Genpharm Inc., Tentatively Approved, posted
9/28/01

Foradil (Formoterol Fumarate Inhalation Powder) Aerolizer, Novartis
Pharmaceuticals, posted 9/26/01

Lupron Depot & Lupron Depot-3 Month (leuprolide acetate), TAP
Pharmaceutical Products, Inc., posted 9/26/01

Nabumetone Tablets, Teva Pharmaceuticals USA, posted 9/26/01

http://www.fda.gov/cder/foi/nda/index97.htm
Flucinonide Ointment USP, Drug Approval Package, posted 9/28/01

Cholestyramine Oral Suspension, Drug Approval Package, posted 9/28/01

Nizoral A-D (Ketoconazole) Shampoo, posted 9/28/01


Drug Information  (Updated 9/13/2001)

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 9/13/2001)
http://www.fda.gov/cder/approval/index.htm

Loratadine Syrup, Geneva Pharmaceuticals, Inc., posted 9/13/01

Tobramycin Ophthalmic Solution USP, Altana Inc., posted 9/13/01

Vecuronium Bromide for Injection, Abbott Laboratories, posted 9/13/01

Xeloda (Capecitabine) Tablets, Roche, posted 9/10/01


Fluoxetine Capsules USP, Eon Labs Manufacturing, Inc., Tentatively
Approved, posted 9/13/01

Fluoxetine Hydrochloride Tablets, Eon Labs Manufacturing, Inc.,
Tentatively Approved, posted 9/13/01

Lisinopril Tablets USP, Mylan Pharmaceuticals, Inc., Tentatively
Approved, posted 9/13/01


CombiPatch (estradiol/norethindrone acetate) transdermal system, Drug
Approval Package, posted 9/14/01

Cozaar (losartan potassium) Tablets, Drug Approval Package, posted
9/14/01

Flonase (fluticasone propionate) Nasal Spray, Drug Approval Package,
posted 9/14/01

Lanoxin (Digoxin) Injection & Pediatric Injection & Lanoxicaps (Digoxin
In Solution) Capsules, Drug Approval Package, posted 9/14/01

Proscar (Finasteride), Drug Approval Package, posted 9/14/01

SonoRx, simethicone coated cellulose suspension, Drug Approval Package,
posted 9/14/01

Warning and Untitled Letters-2001 (9/14/2001)
http://www.fda.gov/cder/warn/warn2001.htm


Drug Information  (Updated 9/07/2001)
-------------------------------------------------
Consumer Drug Information Page
Lantus,
http://www.fda.gov/cder/consumerinfo/druginfo/lantus.htm
NovoLog,
http://www.fda.gov/cder/consumerinfo/druginfo/novolog.htm
Cetrotid,
http://www.fda.gov/cder/consumerinfo/druginfo/cetrotid.htm
Integrilin,
http://www.fda.gov/cder/consumerinfo/druginfo/integril.htm
and Priftin. (9/7/2001)
http://www.fda.gov/cder/consumerinfo/druginfo/priftin.htm

Generic Drug Approvals List (9/6/2001)
http://www.fda.gov/cder/ogd/approvals/default.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 9/5/2001)
http://www.fda.gov/cder/approval/index.htm

Adenoscan (Adenosine) Injection, Fujisawa Healthcare, Inc., posted
9/5/01

Thalomid (thalidomide) Tablets, Celgene Corporation, posted 9/5/01

Topamax (topiramate) Tablets & Topamax (topiramate) Sprinkle Capsules,
R.W. Johnson, posted 9/5/01

Tricor (Fenofibrate) Tablets, Abbott Laboratories, posted 9/5/01


Nexium (esomeprazole magnesium) Delayed-Release Capsules, Drug Approval
Package, posted 9/7/01

Epivir-HBV (lamivudine) Tablets and Oral Solution, Drug Approval
Package, posted 9/7/01

Rebetol (ribavirin)/Intron A (interferon alfa-2b, recombinant), Drug
Approval Package, posted 9/7/01

Singulair (Montelukast Sodium) Chewable Tablets, Drug Approval Package,
posted 9/7/01

 

Top

Drug Information  (Updated 8/29/2001)
-------------------------------------------------
Drug Shortages
http://www.fda.gov/cder/drug/shortages
Cortrosyn (Corjsyntropin) Injection 8/29/2001

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 8/31/2001)
http://www.fda.gov/cder/approval/index.htm

Propranolol Hydrochloride Injection USP, American Pharmaceutical
Partners, Inc., posted 8/31/01

Ciprofloxacin Tablets USP, Genpharm Inc., Tentatively Approved, posted
8/31/01

Fluoxetine Hydrochloride Tablets, Barr laboratories, Tentatively
Approved, posted 8/31/01

Phentermine Hydrochloride Capsules USP, Able Laboratories Inc., posted
8/30/01

Haloperidol Injection, Gensia Sicor Pharmaceuticals, Inc., posted
8/29/01

Lorazepan Tablets USP, Ranbaxy Laboratories Ltd., posted 8/29/01

Prednisone Tablets USP, Trigen Laboratories, Inc., posted 8/29/01

Spectracef (Cefditoren Pivoxil) Tablets, TAP Pharmaceutical Products
Inc., posted 8/29/01

Visudyne (verteporfin) Injection, QLT, Inc., posted 8/29/01


Keppra (levetiracetam) Tablets, Drug Approval Package, posted 8/30/01

Prozac (fluoxetine HCI.) Tablets, Drug Approval Package, posted 8/30/01

Top

Drug Information  (Updated 8/24/2001)
-------------------------------------------------
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 8/24/2001)
http://www.fda.gov/cder/approval/index.htmhttp://www.fda.gov/cder/approval/index.htm

Pamidronate Disodium Injection, American Pharmaceutical Partners Inc.,
posted 8/24/01

Amiodarone Hydrochloride Injection, American Pharmaceutical Partners,
Inc., posted 8/23/01

Fluoxetine Hydrochloride Tablets, Dr. Reddy's Laboratories Ltd.,
Tentatively Approved, posted 8/23/01

Clobetasol Propionate Cream USP, Stiefel Laboratories, posted 8/22/01

Phrenilin w/Caffeine & Codeine (Butalbital, Acetaminophen, Caffeine, &
Codeine Phosphate), Amarin Pharmaceuticals, Inc., posted 8/22/01

Aredia (pamidronate disodium for injection), Novartis Pharmaceuticals
Corporation, posted 8/21/01

Zometa (Zoledronic Acid) Injection, Novartis Pharmaceuticals
Corporation, posted 8/21/01

Spironolactone Tablets USP, Mylan Pharmaceuticals, posted 8/20/01

Flecainide Acetate Tablets USP, Geneva Pharmaceuticals Technology Corp,
Tentatively Approved, posted 8/20/01


Bromocriptine Mesylate Capsules USP, Drug Approval Package, posted
8/24/01

Diltiazem Hydrochloride Injection, Drug Approval Package, posted 8/24/01

Hydrocortisone Valerate Cream USP, Drug Approval Package, posted 8/24/01

Hydrocortisone Valerate Ointment USP, Drug Approval Package, posted
8/24/01

Isosorbide Mononitrate Extended-release tablets, Drug Approval Package,
posted 8/24/01

Terazosin Hydrochloride Capsules, Tentatively Approved, Drug Approval
Package, posted 8/24/01

Tretinoin Cream USP, 0.1%, Drug Approval Package, posted 8/24/01

Tretinoin Cream USP, 0.05%, Drug Approval Package, posted 8/24/01

Tretinoin Cream USP, 0.025%, Drug Approval Package, posted 8/24/01

Diclofenac Sodium Delayed-release Tablets USP, Drug Approval Package ,
posted 8/23/01

Verapamil Hydrochloride Extended-release Tablets USP, Drug Approval
Package , posted 8/23/01

Nifedipine Extended-release Tablets, Drug Approval Package , posted
8/23/01

Cefaclor Capsules USP, Drug Approval Package , posted 8/23/01

Diltiazem Hydrochloride Extended-release Capsules USP, Drug Approval
Package , posted 8/22/01

Abreva Cream , Drug Approval Package, posted 8/21/01

Aleve Cold and Sinus, Drug Approval Package, posted 8/21/01

Alphagan P (brimonidine tartrate ophthalmic solution), Drug Approval
Package, posted 8/21/01

Monistat 3 Combination Pak, Drug Approval Package, posted 8/21/01

NasalCrom Nasal Spray, Drug Approval Package, posted 8/21/01

Lotrel (Amiodipine Besylate/Benazepril Hydrochloride) Capsules, Drug
Approval Package, posted 8/21/01

Travatan (travoprost ophthalmic solution), Drug Approval Package, posted
8/20/01

Lumigan (bimatoprost ophthalmic solution), Drug Approval Package, posted
8/20/01

Top

Drug Information  (8/10/2001)

Drug Information
-------------------------------------------------
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 8/10/2001)
http://www.fda.gov/cder/approval/index.htm

Butorphanol Tartrate Nasal Spray, ESI Lederle, posted 8/10/2001

Zyrtec-D 12 hr. Extended-Release Tablets, Pfizer, posted 8/10/2001

Metipranolol Ophthalmic Solution, Falcon Pharmaceuticals, Ltd., posted
8/8/2001


Doubtrex (Dobutamine HCI) Injection, Drug Approval Package, posted
8/8/2001

Zestril (lisinopril) Tablet supp. 33 & 34, Drug Approval Package, posted
8/8/2001

Provera (Medroxyprogesterone Acetate Tablets, Drug Approval Package,
posted 8/6/2001

Cordarone (Amiodarone HCI) Tablets, Drug Approval Package, posted
8/6/2001

Zoladex (goserelin acetate) Implant, Drug Approval Package, posted
8/6/2001

Zoladex (goserelin acetate) Depot, Drug Approval Package, posted
8/6/2001

Lupron Depot (leuprolide acetate) 3.75 mg & 11.25 mg, Drug Approval
Package, posted 8/6/2001

Caverject (Alprostadil for Injection) Sterile Powder, Drug Approval
Package, posted 8/6/2001

Micardis (telmisartan) Tablets, Drug Approval Package, posted 8/6/2001

Preparation T (Brand of Testosterone Pellets, USP, Drug Approval
Package, posted 8/6/2001


Warning and Untitled Letters-2001 (8/10/2001)
http://www.fda.gov/cder/warn/warn2001.htm

FDA Drug Approvals List (8/10/2001)
http://www.fda.gov/cder/da/da.htm

Drug Shortages
http://www.fda.gov/cder/drug/shortages
Resolved: Isuprel (isoproterenol) Injection 8/10/2001
Narcan (Naloxone) 8/10/2001
Diphenhydramine injection 8/10/2001

Approved Drug Products with Therapeutic Equivalence: Query (8/8/2001)
http://www.fda.gov/cder/ob/default.htm

Approved Drug Products with Therapeutic Equivalence Evaluations-21st
Edition (Cumulative Supplement-5) (8/7/2001)
http://www.fda.gov/cder/orange/supplement/cspreface.htm
[Information and Data Files] (8/7/2001)
http://www.fda.gov/cder/orange/obreadme.htm

Approved Drug Products with Therapeutic Equivalence Evaluations Monthly
Additions and Deletions (May) (8/6/2001)
http://www.fda.gov/cder/rxotcdpl/pdpl_200105.htm


Regulatory Information
-------------------------------------------------
Patent Term Extension and New Patents Docket Number *95S-0117
(8/7/2001)
http://www.fda.gov/cder/orange/docket.pdf


Drug Information  (7/27/2001)

Drug Information
-------------------------------------------------
FDA's Drug Review and Approval Times (7/27/2001).
http://www.fda.gov/cder/reports/reviewtimes/default.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 7/27/2001)
http://www.fda.gov/cder/approval/index.htm

Cephalexin Powder Oral Suspension, Ranbaxy Laboratories Limited, posted
7/27/2001

Paclitaxel Injection, Bedford Laboratories, posted 7/27/2001

Cromolyn Sodium Nasal Solution USP, Alpharma, posted 7/26/2001

Lactulose Oral Solution, Vintage Pharmaceuticals, Inc., posted 7/26/2001

Megestrol Acetate Oral Suspension, Par Pharmaceutical, Inc., posted
7/26/2001

Rebetol (ribavirin)/Intron A (interferon alfa-2b) (Rebetron Combination
Therapy, Schering Corporation, posted 7/26/2001

Butalbital, Acetaminophen and Caffeine Tablets USP, Able Laboratories,
posted 7/24/2001

Butalbital, Acetaminophen and Caffeine Tablets USP, Able Laboratories,
posted 7/24/2001

Famotidine Tablets USP, TorPharm, posted 7/24/2001

Ketorolac Tromethamine Injection USP, Apotex Corp., posted 7/24/2001

Paclitaxel Injection, Mylan Pharmaceuticals, Inc., posted 7/24/2001



Plan B (Levonorgestrel) Tablets, Drug Approval Package, posted 7/26/2001

Precedex (dexmedetomidine hcl injection), Drug Approval Package, posted
7/26/2001

Zoloft (sertraline hydrochloride) Tablets, Drug Approval Package, posted
7/26/2001

Top

Drug Information  (7/19/2001)

Drug Information
-------------------------------------------------
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 7/19/2001)
http://www.fda.gov/cder/approval/index.htm

Ciprofloxacin Tablets USP, Mylan Pharmaceuticals, Inc., posted 7/19/2001

Lovastatin Tablets USP, TEVA Pharmaceuticals, USA, Tentatively Approved,
posted 7/19/2001

Lovastatin Tablets USP, Mylan Pharmaceuticals, Inc., Tentatively
Approved, posted 7/19/2001

Lovastatin Tablets USP, Genpharm Inc., Tentatively Approved, posted
7/19/2001

Lovastatin Tablets USP, Geneva Pharmaceuticals, Tentatively Approved,
posted 7/19/2001

Lovastatin Tablets USP, Eon Labs Manufacturing, Inc., Tentatively
Approved, posted 7/19/2001

Diovan (Valsartan) Tablet, Novartis Pharmaceuticals Corporation, posted
7/18/2001

Enpresse-21 Tablets & Enpresse-28 Tablets, Duramed Pharmaceuticals,
Inc., posted 7/17/2001


Avelox (moxifloxacin HCl) Tablet, Drug Approval Package, posted
7/18/2001

Gyne Lotrimin 3, Drug Approval Package , posted 7/18/2001

Lodine XL (etodolac extended-release tablets) Tablets, Drug Approval
Package , posted 7/18/2001

Mobic (meloxicam) Tablets, Drug Approval Package, posted 7/18/2001

Primaxin I.M. (imipenem and cilastatin) Injectable Suspension, Drug
Approval Package, posted 7/18/2001

Toprol XL (Metoprolol Succinate) Tablets, Drug Approval Package, posted
7/18/2001

Axid (nizatidine) Tablets, Drug Approval Package, posted 7/18/2001

Monistat 3 Vaginal Cream (Miconazole Nitrate), Drug Approval Package,
posted 7/18/2001

PYLORI-CHEK Breath test (13C urea), Drug Approval Package , posted
7/18/2001

Advil Chewable Tablets (ibuprofen tablet), Drug Approval Package, posted
7/18/2001

Tequin (Gatifloxacin) Tablets & IV, Drug Approval Package, posted
7/18/2001

Rescula (unoprostone isopropyl) Ophthalmic Solution, Drug Approval
Package , posted 7/18/2001

Azulfidine EN-tabs (sulfasalazine) Tablets, Drug Approval Package,
posted 7/18/2001

Maxipime (Cefepime Hydrochloride) Injection, Drug Approval Package,
posted 7/18/2001

Banan (cefpodoxime proxetil) Tablets and Suspension, Drug Approval
Package , posted 7/18/2001

SYNERCID I.V. (quinupristin and dalfopristin for injection), Drug
Approval Package, posted 7/18/2001

Cleocin Vaginal Ovules (clindamycin phosphate vaginal suppositories),
Drug Approval Package, posted 7/18/2001

Vasotec (Enalapril Maleate) Tablets, Drug Approval Package , posted
7/18/2001


Drug Information  (7/6/2001)
-------------------------------------------------
FDA Drug Approvals List (7/6/2001)

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 7/6/2001)
http://www.fda.gov/cder/approval/index.htm

Carbamazepine (Chewable) Tablets USP, Caraco Pharmaceutical
Laboratories, Ltd., posted 7/6/2001

Cromolyn Sodium Nasal Solution USP, Bausch & Lomb Pharmaceuticals, Inc.,
posted 7/3/2001

Monistat 3 Combination Pak, Personal Products, posted 7/3/2001

Trelstar Depot (triptorelin pamoate for injectable suspension), Debio
Recherche Pharmaceutique S.A. c/o Target Research Associates, posted
7/3/2001


Cordarone (Amiodarone HCI) Tablets, Drug Approval Package , posted
7/5/2001

Integrilin (eptifibatide) Injection, Drug Approval Package , posted
7/5/2001

Prevacid (lansoprazole) Delayed-Release Capsules, Drug Approval Package
, posted 7/5/2001

Singulair (Montelukast Sodium) Chewable Tablets, Drug Approval Package ,
posted 7/5/2001

Singulair (Montelukast Sodium) Tablets, Drug Approval Package , posted
7/5/2001

Taxotere (docetaxel), Drug Approval Package , posted 7/5/2001

Teveten (Eprosartan Mesylate) Tablets, Drug Approval Package , posted
7/5/2001

Drug Approval Package , posted 7/5/2001

Drug Approval Package , posted 7/5/2001

Climara (estradiol transdermal system), Drug Approval Package , posted
7/3/2001

Cardizem CD ( Diltiazem Hydrochloride) Capsules, Drug Approval Package ,
posted 7/3/2001

Estrostep (Norethindrone Acetate & Ethinyl Estradiol) Tablets, Drug
Approval Package , posted 7/3/2001

Cosopt/dorzolamide HCl and timolol maleate ophthalmic solution, Drug
Approval Package , posted 7/3/2001

Aggrenox (aspirin/extended-release dipyridamole) Capsules., Drug
Approval Package , posted 7/2/2001

Aggrastat (tirofiban hydrochloride) Injection & Premixed Injection, Drug
Approval Package , posted 7/2/2001

Chirocaine (levobupivacaine injection), Drug Approval Package , posted
7/2/2001

Curosurf (poractant alfa) Intratracheal Suspension, Drug Approval
Package , posted 7/2/2001

Raplon (rapacuronium bromide) Injection, Drug Approval Package , posted
7/2/2001

Consumer Drug Information Page
Starlix (7/5/2001)
http://www.fda.gov/cder/consumerinfo/druginfo/starlix.htm


Update (6/18/2001)

Drug Information
-------------------------------------------------
FDA Drug Approvals List (6/18/2001) 
http://www.fda.gov/cder/da/da.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 6/18/2001)
http://www.fda.gov/cder/approval/index.htm

Dacarbazine for Injection USP, Bedford Laboratories, posted 6/18/2001

Haloperidol Injection, Bedford Laboratories, posted 6/18/2001

Lovastatin Tablets USP, Eon Labs Manufacturing, Inc., posted 6/18/2001

Lovastatin Tablets USP, Genpharm Inc., posted 6/18/2001

Lovastatin Tablets USP, Mylan Pharmaceuticals, Inc., posted 6/18/2001

Lovastatin Tablets USP, TEVA Pharmaceuticals, USA, posted 6/18/2001

Lovastatin Tablets USP, Geneva Pharmaceuticals, posted 6/18/2001

Protonix (pantoprazole sodium) Delayed-Release Tablets, Drug Approval
Package, posted 6/18/2001

Reglan (metoclopramide) Tablets, Injection, & Syrup, Drug Approval
Package, posted 6/18/2001

Cykokapron (tranexamic acid) Tablets & Injection., Drug Approval
Package, posted 6/18/2001

Celebrex Capsules, Drug Approval Package, posted 6/18/2001


Update (6/8/2001)

Drug Information
-------------------------------------------------
FDA Drug Approvals List (6/8/2001) 
http://www.fda.gov/cder/da/da.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 6/8/2001)
http://www.fda.gov/cder/approval/index.htm

Doxazosin Mesylate Tablets, Sidmak Laboratories, Inc., posted 6/8/2001

Integrilin (eptifibatide) Injection, COR Therapeutics, Inc., posted
6/8/2001

Enalapril Maleate and Hydrochlorothiazide Tablets USP, Teva
Pharmaceuticals, Tentatively Approved, posted 6/8/2001

Perphenazine Oral Solution USP, Pharmaceutical Associates, Inc., posted
6/5/2001

Triamcinolone Acetonide Ointment USP, Thames Pharmacal Co., Inc., posted
6/5/2001

Syprine (Trientine Hydrochloride) Capsules, Drug Approval Package,
posted 6/8/2001

Coumadin/Warfarin Sodium Tablets and Injection, Drug Approval Package,
posted 6/8/2001

Tricor (fenofibrate) Capsules-Micronized, Drug Approval Package, posted
6/8/2001

Prilosec (omeprazole) Delayed-Release Capsules, Drug Approval Package,
posted 6/8/2001

Propulsid (Cisapride) Tablets, Suspension, & Propulsid Quicksolv
Rapidly-Disintegrating Tablets, Drug Approval Package, posted 6/8/2001

Prevacid (lansoprazole) Delayed-Release Capsules, Drug Approval Package,
posted 6/8/2001

Amaryl (glimepiride Tablets, Drug Approval Package, posted 6/8/2001

Accolate (Zafirlukast) Tablets, Drug Approval Package, posted 6/8/2001

Propulsid (Cisapride) Tablets, Suspension, & Propulsid Quicksolv
Rapidly-Disintegrating Tablets, Drug Approval Package, posted 6/8/2001

Bupropion Hydrochloride Tablets, Drug Approval Package, posted 6/7/2001

Tretinoin Gel USP, Drug Approval Package, posted 6/7/2001

Pentazocine & Naloxone Hydrochloride, Drug Approval Package, posted
6/7/2001

Primsol Solution (Trimethoprim Hydrochloride Oral Solution), Drug
Approval Package, posted 6/7/2001

Ursodiol Capsules USP, Drug Approval Package, posted 6/7/2001

Diclofenac Sodium extended-release Tablets USP, Drug Approval Package,
posted 6/7/2001

Cyclosporine Capsules USP, Drug Approval Package, posted 6/7/2001

Cyclosporine Oral Solution USP (modified), Drug Approval Package, posted
6/7/2001

Acetaminophen Extended-release Tablets, Drug Approval Package, posted
6/7/2001

Estradiol Transdermal System, Drug Approval Package, posted 6/7/2001

Estradiol Transdermal System, Drug Approval Package, posted 6/7/2001

Nitrostat (nitroglycerin sublingual Tablets, Drug Approval Package,
posted 6/7/2001

Venofer (iron sucrose injection), Drug Approval Package, posted 6/7/2001

Cozaar (losartan potassium) Tablets, Drug Approval Package, posted
6/6/2001

Hyzaar (losartan potassium / hydrochlorothiazide) Tablets, Drug
Approval Package, posted 6/6/2001

Aggrastat (tirofiban hydrochloride) Injection & Premixed Injection, Drug
Approval Package, posted 6/6/2001

Atacand (candesartan cilexetil), Drug Approval Package, posted 6/6/2001

Avalide (irbesartan/hydrochlorothiazide) Tablets, Drug Approval Package,
posted 6/6/2001

Avapro (irbesartan) Tablets, Drug Approval Package, posted 6/6/2001

Tiazac/Diltiazem Hydrochloride) Capsules, Drug Approval Package, posted
6/6/2001

Norvasc (amlodipine besylate) Tablets, Drug Approval Package, posted
6/6/2001

Ticlid (Ticlopidine Hydrochloride) Tablets, Drug Approval Package,
posted 6/4/2001

Tenoretic (Atenolol & Chlorthalidone) Tablets, Drug Approval Package,
posted 6/4/2001

Tenormin (Atenolol) Tablets, Drug Approval Package, posted 6/4/2001

Novantrone (mitoxantrone for Injection Concentrate), Drug Approval
Package, posted 6/4/2001

Norvasc (amlodipine besylate) Tablets, Drug Approval Package, posted
6/4/2001

Brevibloc (Esmolol Hydrochloride) Injection, Drug Approval Package,
posted 6/4/2001

Sular (nisoldipine) Extended Release Tablets, Drug Approval Package,
posted 6/4/2001

Dobutamine Hydrochloride & 5% Dextrose Injection USP, Drug Approval
Package, posted 6/4/2001

Mylotarg (Gemtuzumab Ozogamicin) Injection, Drug Approval Package,
posted 6/4/2001

Magnevist Pharmacy Bulk Package, Drug Approval Package, posted 6/4/2001

Camptosar Injection (irinotecan hydrochloride injection), Drug Approval
Package, posted 6/4/2001

Fludeoxyglucose F-18 Injection, Drug Approval Package, posted 6/4/2001

Drug Shortages 
http://www.fda.gov/cder/drug/shortages/default.htm
Dexamethasone Injection (6/5/2001) 
Celeston Soluspan (Betamethasone Injection) (6/5/2001)


(Updated 6/05/2001)

Drug Information
-------------------------------------------------
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 5/31/2001)
http://www.fda.gov/cder/approval/index.htm

Acetaminophen and Codeine Tablets, Mallinckrodt Inc., posted 5/31/2001

Cefuroxime Injection, American Pharmaceutical Partners, posted
5/31/2001

Clotrimazole & Betamethasone Diproprionate Cream, Taro Pharmaceuticals
U.S.A., Inc., posted 5/31/2001

Famotidine Tablets USP, TEVA Pharmaceuticals, posted 5/31/2001

Ciprofloxacin Tablets USP, Geneva Pharmaceuticals, Inc., Tentatively
Approved, posted 5/31/2001

Divalproex Sodium Delayed-release Tablets, Torpharm Inc., Tentatively
Approved, posted 5/31/2001

Lamictal Tablets and Lamictal Chewable Dispersible Tablets, Glaxo
Wellcome, 5/29/2001 

Levoxyl (levothyroxine sodium tablets, USP), Jones Pharma Inc., posted
5/29/2001 

Trileptal Oral Suspension, Novartis Pharmaceuticals Corporation, Posted
5/29/2001 


(Updated 5/11/2001)

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
http://www.fda.gov/cder/approval/index.htm

Gleevec (imatinib mesylate) capsules, Novartis Pharmaceuticals
Corporation, 5/11/2001 

Famotidine Injection, Baxter Healthcare Corp., posted 5/10/2001

Methylphenidate Hydrochloriade Extended-release Tablets USP, Able
Laboratories, Inc., posted 5/10/2001

Pranactin-Citric, Meretek Diagnostics, Inc., posted 5/10/2001

Buspirone Hydrochloride Tablets USP, Torpharm, Tentatively Approved,
posted 5/10/2001

Fluoxetine Oral Solution USP, Alpharma, Tentatively Approved, posted
5/10/2001

Fluvoxamine Maleate Tablets, Topharm, posted 5/9/2001

Prevacid (lansoprazole) Delayed-Release Oral Suspension, TAP
Pharmaceutical Products, Inc., posted 5/9/2001

Omeprazole delayed-release Capsules, Kremers Urban Development Co.,
Tentatively Approved, posted 5/9/2001

Axert (almotriptan) Tablets, Pharmacia & Upjohn, posted 5/8/2001


About CDER  (2/28/2001)
-------------------------------------------------
Drug Information
-------------------------------------------------
Drug Shortages (3/2/2001) 
http://www.fda.gov/cder/drug/shortages/default.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 3/1/2001)
http://www.fda.gov/cder/approval/index.htm

Oxaprozin Tablets, Genpharm Inc., posted 3/1/2001

Prozac (fluoxetine HCI.) Tablets, Eli Lilly, posted 3/1/2001

Reminyl (galantamine hydrobromide) Tablets, Janssen Research Foundation,
posted 3/1/2001

Metaproterenol Sulfate Inhalation Solution USP, Novex Pharma, posted
2/28/2001

Famotidine Injection, American Pharmaceutical Partners, Inc.,
Tentatively Approved, posted 2/28/2001

Micort-HC Lipocream (Hydrocortisone Acetate Cream USP), Ferndale
Laboratories, Inc., posted 2/27/2001

Diclofenac Potassium Tablets, Eon Labs manufacturing, Inc., posted
2/26/2001

Diprivan (propofol) Injectable Emulsion, AstraZeneca LP, posted
2/26/2001

Infulvite Pediatric (Multiple Vitamins for Infusion) IV, Sabex Inc.,
posted 2/26/2001

Penicillin G Sodium for Injection USP, Biochemie GmbH, posted 2/26/2001

Warning and Untitled Letters-2001 (2/28/2001) 
http://www.fda.gov/cder/warn/warn2001.htm

Approved Drug Products with Therapeutic Equivalence: Query (2/28/2001) 
http://www.fda.gov/cder/ob/default.htm

Approved Drug Products with Therapeutic Equivalence Evaluations-20th
Edition (Cumulative Supplement-12) (2/27/2001)
http://www.fda.gov/cder/orange/supplement/cspreface.htm
[Information and Data Files] (2/27/2001) 
http://www.fda.gov/cder/orange/obreadme.htm

Approved Drug Products with Therapeutic Equivalence Evaluations Monthly
Additions and Deletions (December 2000) (2/27/2001) 
http://www.fda.gov/cder/rxotcdpl/pdpl_200011.htm

FDA Drug Approvals List (2/26/2001)
http://www.fda.gov/cder/da/da.htm


Drug Information  (2/1/2001)
-------------------------------------------------
Clozapine Issue Paper (2/1/2001) 
http://www.fda.gov/cder/drug/infopage/clozapine/clozapine.htm

Targretin (1/31/2001) 
http://www.fda.gov/cder/consumerinfo/druginfo/targret.HTM

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 2/2/2001
http://www.fda.gov/cder/approval/index.htm

Clindamycin Hydrochloride Capsules USP, Ranbaxy Laboratories Limited,
posted 2/2/01

Periostat (doxycycline hyclate) Tablets, CollaGenex Pharmaceuticals,
posted 2/2/01

Fluoxetine Capsules USP, Apothecon Inc., Tentatively Approved, posted
2/2/01

Fosamax (alendronate sodium) Tablets, Merck & Co., Inc., posted 2/1/01

Leucovorin Calcium for Injection, Luitpold Pharmaceuticals, Inc., posted
2/1/01

Lisinopril Tablets USP, TEVA Pharmaceuticals USA, Tentatively Approved,
posted 1/31/01

Morphine Sulfate Extended-release Tablets, Watson Laboratories, Inc.,
posted 1/31/01

Oxaprozin Tablets, Eon labs manufacturing, Inc., posted 1/31/01

Oxaprozin Tablets, Dr. Reddy's Laboratories Limited, posted 1/31/01

Phenytoin Oral Suspension USP, UDL Laboratories, Inc., posted 1/31/01

Terazosin Hydrochloride Capsules, Zenith Goldline Pharmaceuticals, Inc.,
posted 1/31/01

Metoclopramide Oral Solution USP, UDL Laboratories, Inc., posted 1/29/01

Loratadine Syrup, Teva Pharmaceuticals USA, Tentatively Approved, posted
1/29/01


Drug Information (1/26/2001) 
-------------------------------------------------
FDA Drug Approvals List (1/26/2001) 
http://www.fda.gov/cder/da/da.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 1/26/2001)
http://www.fda.gov/cder/approval/index.htm

Amiodarone Hydrochloride Tablets, Barr Laboratories, Inc., posted
1/26/01

Cromolyn Sodium Ophthalmic Solution, Novex Pharma, posted 1/26/01

Fluvoxamine Maleate Tablets, Barr Laboratories, Inc., posted 1/26/01

Ipratropium Bromide Inhalation Solution, Aslung Pharmaceutical, L.P.,
posted 1/26/01

Enalapril Maleate Tablets USP, Taro Pharmaceutical, 1/24/2001 


Famotidine Injection, Bedford Laboratories, Tentatively approved, posted
1/26/01

Famotidine Injection, Ben Venue Laboratories, Inc., Tentatively
approved, posted 1/26/01

Antimicrobial Resistance Page (1/25/2001) 
http://www.fda.gov/cder/drug/antimicrobial/default.htm

Drug Shortages (1/25/2001) 
http://www.fda.gov/cder/drug/shortages/default.htm

Accutane (Isotretinoin) Information Page (1/23/2001) 
http://www.fda.gov/cder/drug/infopage/accutane/default.htm


Drug Information (1/19/2001)
-------------------------------------------------
FDA Drug Approvals List (1/19/2001) 
http://www.fda.gov/cder/da/da.htm

Drug Master Files (1/16/2001) 
http://www.fda.gov/cder/dmf/index.htm

FDA Drug Approvals List (1/19/2001) 
http://www.fda.gov/cder/da/da.htm

National Drug Code (NDC) Directory (Updated 1/16/2001) 
http://www.fda.gov/cder/ndc/index.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 1/19/2001
http://www.fda.gov/cder/approval/index.htm

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, Teva
Pharmaceuticals, posted 1/19/2001

Ipratropium Bromide Inhalation Solution, Warrick Pharmaceuticals, posted
1/19/2001


Fluvoxamine Maleate Tablets, Synthon Pharmaceuticals, Ltd., posted
1/17/2001 

Remeron Soltab (mirtazapine) Orally Disintegrating Tablets, Organon,
posted 1/16/2001 

Warning and Untitled Letters-2000 (1/19/2001) 
http://www.fda.gov/cder/warn/warn2000.htm

Warning and Untitled Letters-2001 (1/19/2001) 
http://www.fda.gov/cder/warn/warn2001.htm

Top

Drug Information  (01/05/2001)
-------------------------------------------------
FDA/Bristol-Myers Squibb issues caution for HIV Combination therapy with
Zerit and Videx in Pregnant women. FDA Talk Paper.
http://www.fda.gov/bbs/topics/ANSWERS/ANS01063.html
Letter from Bristol-Myers Squibb.
http://www.fda.gov/medwatch/safety/2001/safety01.htm#zerit
Revised labels for Zerit;
http://www.fda.gov/cder/foi/label/2001/zeritwng.pdf
Videx; and
http://www.fda.gov/cder/foi/label/2001/videxlbl.pdf
Videx EC. (1/5/01) 
http://www.fda.gov/cder/foi/label/2001/videxec.pdf

FDA Drug Approvals List (1/5/2001) 
http://www.fda.gov/cder/da/da.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 1/5/2001
http://www.fda.gov/cder/approval/index.htm

Cefaclor Extended-release Tablets, USP, Zenith Goldline Pharmaceuticals,
Inc., posted 1/5/2001 

Valproic Acid Syrup USP, UDL Laboratories, Inc., posted 1/2/2001


Drug Information (12/27/2000)
-------------------------------------------------
Drug Shortages (12/27/2000) 
http://www.fda.gov/cder/drug/shortages/default.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 12/27/2000)
http://www.fda.gov/cder/approval/index.htm

Clobetasol Propionate Topical Solution USP, Thames Pharmacal Co., Inc.,
posted 12/29/2000

Hydrocortisone Valerate Ointment USP, Thames Pharmacal Co., Inc., posted
12/29/2000

Oxycodone and Acetaminophen Tablets USP, Watson Laboratories, Inc.,
posted 12/29/2000

Fluvoxamine Maleate Tablets, Purepac Pharmaceutical Co., posted
12/28/2000, posted 12/28/2000

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, Apothecon, Inc,
12/27/2000 

Detrol LA Capsules, Pharmacia and Upjohn, posted 12/26/2000

Famotidine Injection, Bedford Laboratories, (Tentatively Approved),
posted 12/26/2000

Starlix (nateglinide) Oral Tablets, Novartis, posted 12/26/2000


Drug Information (12/21/2000)
-------------------------------------------------
FDA Proposed New Format for Physician Rx Drug Labeling (12/21/2000) 
http://www.fda.gov/bbs/topics/NEWS/NEW00745.html

Generic Drug Approvals (12/20/2000) 
http://www.fda.gov/cder/ogd/approvals/default.htm

Warning and Untitled Letters-2000 (12/20/2000) 
http://www.fda.gov/cder/warn/warn2000.htm

Drug Shortages (12/19/2000) 
http://www.fda.gov/cder/drug/shortages/default.htm

FDA Drug Approvals List (12/22/2000) 
http://www.fda.gov/cder/da/da.htm

Lotronex Page Updated (12/18/2000) 
http://www.fda.gov/cder/drug/infopage/lotronex/lotronex.htm

Letter Regarding Lotronex from Dr. Janet Woodcock, Director, Center for
Drug Evaluation and Research (12/18/2000) 
http://www.fda.gov/cder/drug/infopage/lotronex/lontronex-consumerletter.

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 12/22/2000
http://www.fda.gov/cder/approval/index.htm

BenzaClin Topical Gel, Dermik Laboratories, posted 12/22/2000

CellCept (mycophenolate mofetil hydrochloride) Intravenous / Oral
Suspension / Capsules / Tablets, Hoffman La-Roche, posted 12/22/2000

Ciprofloxacin Tablets USP, Danbury Pharmacal, Inc. (Tentatively
Approved), posted 12/22/2000

Carbamazepine Oral Suspension USP, Taro Pharmaceutical Industries Ltd.,
posted 12/21/2000

Cromolyn Sodium Inhalation Solution USP, Bausch & Lomb Pharmaceuticals,
Inc., posted 12/21/2000

Cyclessa (desogestrel/ethinyl estradiol) Tablet, Organon, Inc., posted
12/21/2000

Famotidine Injection, ESI Lederle, posted 12/21/2000

Cyclosporine Capsules USP, Sidmak Laboratories, Inc., posted 12/20/2000

Sotalol Hydrochloride Tablets, Mylan Pharmaceuticals, Inc., posted
12/20/2000

Angiomax (bivalirudin) Injection, The Medicines Company, posted
12/19/2000

Lescol (fluvastatin) Capsules, Novartis Pharmaceutical Corporation,
posted 12/19/2000

Lovastatin Tablets USP, Purepac Pharmaceutical Co., posted 12/19/2000

Doxycycline Tablets, Par Pharmaceutical, Inc., posted 12/18/2000

Glucophage (Metformin Hydrochloride) Tablets, Bristol-Myers Squibb,
posted 12/18/2000

Valproic Acid Syrup USP, Pharmaceutical Associates, Inc., posted
12/18/2000

 

Top

Drug Information (12/15/2000)
-------------------------------------------------
Xeloda (12/15/2000) 
http://www.fda.gov/cder/consumerinfo/druginfo/xeloda.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 12/14/2000

Orapred (Prednisolone Sodium Phosphate) Oral Solution, Ascent
Pediatrics, posted 12/14/2000

Tamiflu (oseltamivir phospate) Oral Suspension,Hoffman-La Roche, posted
12/14/2000

Famotidine Injection, Faulding Pharmaceutical Co., posted 12/13/2000

Famotidine Tablets USP, Cheminor Drugs Limited, posted 12/13/2000

Antizol (femepizole) Injection, Orphan Medical, Inc., posted 12/12/2000

Lotrisone (clotrimazole and betamethasone diproprionate) Lotion,
Schering-Plough Research Institute, posted 12/11/2000


Drug Information (12/6/2000)
-------------------------------------------------
Approved Drug Products with Therapeutic Equivalence Evaluations-20th
Edition (Cumulative Supplement-10) (12/6/2000)
http://www.fda.gov/cder/orange/supplement/cspreface.htm
[Information and Data Files] (12/6/2000) 
http://www.fda.gov/cder/orange/obreadme.htm

Approved Drug Products with Therapeutic Equivalence Evaluations Monthly
Additions and Deletions (October 2000) (12/6/2000) 
http://www.fda.gov/cder/rxotcdpl/pdpl_200010.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 12/8/2000)

Mirena (levonorgestrel-releasing intrauterine system) Intrauterine
delivery system, Berlex Laboratories Inc., posted 12/7/2000

Dextrose Injection USP, Baxter Healthcare, posted 12/6/2000

Nifedipine Extended-release Tablets, Biovail Laboratories Inc., posted
12/6/2000

Terazosin Hydrochloride Capsules, Mylan Technologies, Inc., posted
12/6/2000

Hydrochloride Capsules, Mylan Technologies, Inc., posted 12/4/2000

Paragraph IV Database (12/7/2000) 
http://www.fda.gov/cder/ogd/ppiv.htm

 

Top

Drug Information (11/28/2000) 
-------------------------------------------------

Drug Shortages (11/28/2000) 
http://www.fda.gov/cder/drug/shortages/default.htm

FDA Drug Approvals List (12/1/2000) 
http://www.fda.gov/cder/da/da.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 12/1/2000)
http://www.fda.gov/cder/approval/index.htm

Amoxicillin Tablets USP, Ranbaxy Pharmaceuticals Inc., posted 12/1/2000

Clindamycin Phosphate Topical Gel USP, LLC (Target Research Associate -
US Agent, posted 12/1/2000

Doxycycline Capsules USP, Par Pharmaceuticals Inc., posted 12/1/2000

Fluvoxamine Maleate Tablets, Eon Labs Manufacturing , posted 12/1/2000

Hydrocodone Bitartrate and Homatropine methylbromide Tablets USP, Amide
Pharmaceutical, Inc., posted 12/1/2000

Minocycline Hydrochloride Capsules USP, Ranbaxy Laboratories Limited,
posted 12/1/2000

Prevacid (lansoprazole) Delayed-Release Capsules, Tap Pharmaceutical
Products, Inc., posted 12/1/2000

Benzamycin Pak (erythromycin 3%-benzoyl peroxide 5% topical gel), Dermik
Laboratories, Inc., posted 11/29/2000

Famotidine Tablets USP, Cheminor Drugs Limited, posted 11/29/2000

Ketorolac Tromethamine Injection USP, Apothecon, Inc., posted 11/29/2000

Ranitidine Capsules, Cheminor Drugs Limited, posted 11/29/2000

Clemastine Fumarate Syrup, Novex Pharma, posted 11/27/2000

Diphenoxylate Hydrochloride & Atropine Sulfate Tablets, Able
Laboratories, Inc., posted 11/27/2000

Lovenox (enoxaparin sodium) Injection, Aventis Pharmaceuticals Products
Inc., posted 11/27/2000


Drug Information (Updated 11/21/2000)
-------------------------------------------------
Consumer Drug Information Page
Tamiflu (Updated 11/21/2000)
http://www.fda.gov/cder/consumerinfo/druginfo/tamiflu.htm

Influenza Information Page
http://www.fda.gov/cder/drug/antivirals/influenza/default.htm

Tamiflu Information.
http://www.fda.gov/cder/drug/infopage/tamiflu/default.htm

FDA Drug Approvals List (11/20/2000)
http://www.fda.gov/cder/da/da.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 (Updated 11/24/2000)
http://www.fda.gov/cder/approval/index.htm

Amoxicillin Tablets USP, Ranbaxy Pharmaceuticals Inc., posted 11/24/2000

Doxycycline Capsules USP, Ranbaxy Laboratories Ltd., posted 11/24/2000

Ethosuximide Syrup, Pharmaceutical Associates, Inc., posted 11/24/2000

Micardis (telmisartan) Tablets, Boehringer Ingelheim, posted 11/20/2000

Minoxidil Topical Solution USP, Alpharma, U.S. Pharmaceuticals, posted
11/20/2000

Minoxidil Topical Solution USP, Copley Pharmaceutical, Inc, posted
11/20/2000

Phenylpropanolamine (PPA) Information Page (11/20/2000)
http://www.fda.gov/cder/drug/infopage/ppa/default.htm

Tamiflu: FDA Approves Tamiflu for another Indication -- Prevent of
Influenza (11/20/2000)
http://www.fda.gov/bbs/topics/ANSWERS/ANS01056.html


Drug Information (Updated 11/17/2000)
-------------------------------------------------
Rapamune,
http://www.fda.gov/cder/consumerinfo/druginfo/rapamune.htm
Xenical,
http://www.fda.gov/cder/consumerinfo/druginfo/xenical.htm
Provigil,
http://www.fda.gov/cder/consumerinfo/druginfo/provigil.htm
Pletal,
http://www.fda.gov/cder/consumerinfo/druginfo/pletal.htm
Comtan (Updated 11/17/2000)
http://www.fda.gov/cder/consumerinfo/druginfo/comtan.htm

Drug Master Files (11/16/2000)
http://www.fda.gov/cder/dmf/index.htm

FDA Drug Approvals List (11/3/2000)
http://www.fda.gov/cder/da/da.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 (Updated 11/17/2000
http://www.fda.gov/cder/approval/index.htm

Cisplatin Injection, Bedford Laboratories, posted 11/13/00

Sotalol Hydrochloride Tablets, IMPAX Laboratories, Inc., posted 11/13/00

Venofer (iron sucrose injection), Luitpold Pharmaceuticals, Inc., posted
11/13/00

Zocor (simvastatin) Tablets, Merck, posted 11/13/00

Zyprexa (olanzapine) Tablets, Eli Lilly & Co., posted 11/13/00

Chlorhexidine Gluconate Oral Rinse, Novex Pharma, posted 11/15/00

Cisplatin Injection, Bedford Labs, posted 11/15/00

Fluorouracil Injection USP, Bigmar, Inc., posted 11/15/00

Trizivir (abacavir sulfate, lamivudine, zidovudine), Glaxo Wellcome,
posted 11/15/00

Nizatidine Capsules USP, Mylan Pharmaceuticals, Inc., posted 11/16/2000

Bisoprolol Fumarate Tablets, Eon Labs Manfacturing, Inc., posted
11/17/2000

 

Top


Drug Information
-------------------------------------------------
(11/10/2000)
Buying Prescription Medicines Online:  A Consumer Safety Guide
(11/8/2000)
http://www.fda.gov/cder/drug/consumer/buyonline/guide.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 (Updated 11/6/2000)
http://www.fda.gov/cder/approval/index.htm

Naropin (ropivacaine HCI) Injection, AstraZeneca L.P., posted 11/6/2000

Phenylpropanolamine (PPA) Information Page (11/6/2000)
http://www.fda.gov/cder/drug/infopage/ppa/default.htm

Paragraph IV Database (11/8/2000)
http://www.fda.gov/cder/ogd/ppiv.htm

Generic Drug Approvals (11/9/2000)
http://www.fda.gov/cder/ogd/approvals/default.htm

 



Drug Information
-------------------------------------------------
(11/3/2000)
FDA Drug Approvals List (11/3/2000)
http://www.fda.gov/cder/da/da.htm

Approved Drug with Therapeutic Equivalence Evaluations (Orange Book
Query)  (Updated 11/2/2000)
http://www.fda.gov/cder/ob/default.htm

Approved Drug Products with Therapeutic Equivalence Evaluations-20th
Edition (Cumulative Supplement-9) (11/2/2000)
http://www.fda.gov/cder/orange/supplement/cspreface.htm
[Information and Data Files] (11/2/2000)
http://www.fda.gov/cder/orange/obreadme.htm

Additions and Deletions (September 2000) (11/2/2000)
http://www.fda.gov/cder/rxotcdpl/pdpl_200009.htm

Alamast,
http://www.fda.gov/cder/consumerinfo/druginfo/alamast.htm
Antagon,
http://www.fda.gov/cder/consumerinfo/druginfo/antagon.htm
Avandia,
http://www.fda.gov/cder/consumerinfo/druginfo/avandia.htm
Celebrex (Updated 10/31/2000)
http://www.fda.gov/cder/consumerinfo/druginfo/celebrex.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 (Updated 11/1/2000)
http://www.fda.gov/cder/approval/index.htm

Fluorouracil Cream USP, Dermik Laboratories, Inc., posted 10/30/00

Midazolam Hydrochloride Injection, Apotex Corp., posted 10/31/00

Midazolam Hydrochloride Injection, Apothecon Inc., posted 11/1/00

Videx EC, Bristol-Myers Squibb, posted 11/1/00

Small Business Assistance (11/1/2000)
http://www.fda.gov/cder/about/smallbiz/default.htm

Warning and Untitled Letters-2000 (10/31/2000)
http://www.fda.gov/cder/warn/warn2000.htm

 

Top


Drug Information
-------------------------------------------------
(10/27/2000)
FDA Drug Approvals List (10/27/2000)
http://www.fda.gov/cder/da/da.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 (Updated 10/27/2000
http://www.fda.gov/cder/approval/index.htm

Ranitidine Tablets USP, Genpharm Inc., posted 10/27/00

Carbamazepine (Chewable) Tablets USP, Taro Pharmaceutical Industries
Ltd., posted 10/26/2000

Lescol (fluvastatin sodium) Capsules, Novartis Pharmaceutical
Corporation, posted 10/26/2000

Leuprolide Acetate Injection, Gensia Sicor Pharmaceuticals, Inc., posted
10/26/2000

Nizatidine Capsules USP, Danbury Pharmacal, Inc., posted 10/26/2000

Propafenone Hydrochloride Tablets, Watson Laboratories, Inc., posted
10/26/2000

Doxazosin Mesylate Tablets, Invamed Inc., posted 10/23/2000

Megestrol Acetate Oral Suspension, Par Pharmaceutical, Inc., posted
10/23/2000

Priftin (rifapentine), Aventis Pharmaceuticals, posted 10/23/2000



Drug Information
(10/20/2000)
-------------------------------------------------
Drug Shortages (10/20/2000)
http://www.fda.gov/cder/drug/shortages/default.htm

Influenza Information Page: covers approved influenza antiviral drugs
and related information. (10/16/2000)
http://www.fda.gov/cder/drug/antivirals/influenza/default.htm

FDA Drug Approvals List (10/17/2000)
http://www.fda.gov/cder/drug/default.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 (Updated 10/20/2000)
http://www.fda.gov/cder/approval/index.htm

Biaxin (clarithromycin) Filmtab, Abbott Laboratories, posted 10/20/2000

Fosamax (alendronate sodium) Tablets, Merck Research Laboratories,
posted 10/20/2000

Hydrocodone Bitartrate and Acetaminophen Tablets USP, Mallinckrodt,
Inc., posted 10/20/2000

Glucophage XR (metformin HC1 extended-release) Tablets Bristol-Myers
Squibb, posted 10/17/2000

Doxazosin Mesylate Tablets, Chelsea Laboratories, Inc., posted
10/18/2000

Doxazosin Mesylate Tablets, Eon Labs Manufacturing, Inc., posted
10/18/2000

Doxazosin Mesylate Tablets, KV Pharmaceutical Company, posted 10/18/2000

Doxazosin Mesylate Tablets, Purepac Pharmaceutical Co., posted
10/18/2000

Doxazosin Mesylate Tablets, TEVA Pharmaceuticals, posted 10/18/2000

Doxazosin Mesylate Tablets, Zenith Goldline Pharmaceuticals Inc., posted
10/18/2000

Pepcid Complete Chewable Tablets, Merck Research Laboratories, posted
10/18/2000

Solaraze (diclofenac sodium) Gel, SkyePharma, posted 10/18/2000

Doxazosin Mesylate Tablets, Genpharm, Inc., posted 10/19/2000

Doxazosin Mesylate Tablets, Mylan Pharmaceuticals, Inc., posted
10/19/2000

Doxazosin Mesylate Tablets, TorPharm, posted 10/19/2000

Midazolam Hydrochloride Injection, Apothecon Inc., posted 10/19/2000

Top



Drug Information
-------------------------------------------------
(10/10/2000)
FDA Drug Approvals List (10/10/2000)
http://www.fda.gov/cder/da/da.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 (Updated 10/13/2000)
http://www.fda.gov/cder/approval/index.htm

Novantrone (mitoxantrone hydrochloride) Injection, Immunex Corporation,
posted 10/13/2000

Neurontin (gabapentin) oral solution, capsule & tablet, Parke-Davis
Pharmaceutical Research, posted 10/12/2000

Bupropion Hydrochloride Tablets, Eon Labs Manufacturing, Inc., posted
10/10/2000

Paclitaxel Injection, Zenith Goldline Pharmaceuticals, Inc., posted
10/10/2000

Lescol XL (fluvastatin sodium) Extended release Tablets, Novartis
Pharmaceutical Corporation, posted 10/10/2000

 



Drug Information
(10/4/2000)
-------------------------------------------------
Consumer Drug Information Page
Relenza updated (10/4/2000)
http://www.fda.gov/cder/consumerinfo/druginfo/relenza.htm

Tamiflu updated (10/4/2000)
http://www.fda.gov/cder/consumerinfo/druginfo/tamiflu.htm

FDA approves ramipril (Altace) for reducing risk of heart problems.  FDA
Talk Paper.
http://www.fda.gov/bbs/topics/ANSWERS/ANS01042.html

National Drug Code (NDC) Directory (Updated 10/6/2000)
http://www.fda.gov/cder/ndc/index.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
(Updated 10/6/2000)

Flovent Diskus (fluticasone dipropionate) inhalation powder,
GlaxoWellcome, 10/4/2000

Isosorbide Mononitrate Tablets, Westward Pharmaceutical Corp., posted
10/6/2000

Lunelle Monthly Contraceptive Injection (medroxyprogesterone acetate/ethinyl
estradiol), Pharmacia & Upjohn, Posted 10/6/2000

Oxycodone and Acetaminophen Capsules, Barr Laboratories, posted 10/4/00

Tazorac (tazarotene) Cream, 0.05% & 0.1%, Rx Allergan, posted 10/4/2000

Warning and Untitled Letters-2000 (10/2/2000)
http://www.fda.gov/cder/warn/warn2000.htm

Top


Drug Information
(9/29/2000)
-------------------------------------------------
FDA Drug Approvals List (9/29/2000)
http://www.fda.gov/cder/da/da.htm

Mifepristone (9/28/2000)
http://www.fda.gov/cder/drug/infopage/mifepristone/default.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 (Updated 9/29/2000)
http://www.fda.gov/cder/approval/index.htm

Betaxolol Ophthalmic Solution USP, Novex Pharma, posted 9/29/00

Codamine (Hydrocodone Bitartrate and Phenylpropanolamine)Syrup,
Alpharma, posted 9/29/00

Fosamax (alendronate sodium) Tablets, Merck Research Laboratories,
posted 9/29/00

Lovenox (enoxaparin sodium) Injection, Aventis Pharmaceuticals Products
Inc., posted 9/29/00

Taztia XT (Diltiazem Hydrochloride Extended-release Capsules USP, Andrx
Pharmaceuticals, Inc., posted 9/29/00

Tropicamide Ophthalmic Solution USP, Akorn, Inc., posted 9/29/00

Amaryl (glimepiride Tablets, Metabolic and Endocrine Drug Products,
posted 9/28/2000

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, Zenith Goldline
Pharmaceuticals, Inc., posted 9/28/2000

Luvox (fluvoxamine maleate) Tablets, Solvay Pharmaceuticals, posted
9/28/2000

Mifeprex (mifepristone) Tablet, Population Council, posted 9/28/2000

Nifedipine Extended-release Tablets, Biovail Laboratories Inc., posted
9/28/2000

Paclitaxel Injection, Baker Norton Pharmaceuticals, Inc., posted
9/27/2000

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, Invamed, Inc.

Trisenox (arsenic trioxide) Injection, Cell Therapeutics, Inc., posted
9/26/2000

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, Chelsea
Laboratories, Inc., posted 9/25/2000

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, Purepac
Pharmaceutical Co., posted 9/25/2000

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, Mylan
Pharmaceuticals, Inc., posted 9/25/2000

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, Eon Labs
Manfacturing, Inc., posted 9/25/2000

Warning and Untitled Letters-2000 (9/25/2000)
http://www.fda.gov/cder/warn/warn2000.htm

 



Drug Information
-------------------------------------------------
(9/19/2000)
FDA Drug Approvals List (9/19/2000)
http://www.fda.gov/cder/da/da.htm

Generic Drug Approvals (9/19/2000)
http://www.fda.gov/cder/ogd/approvals/default.htm

Kaletra: FDA Approves Kaletra for HIV Infection (9/18/2000)
http://www.fda.gov/cder/drug/infopage/kaletra/default.htm

Labeling Requirements for Systemic Antibacterial Drug Products Intended
for Human Use (9/19/2000)
http://www.fda.gov/bbs/topics/NEWS/NEW00736.html

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 (Updated 9/22/2000
http://www.fda.gov/cder/approval/index.htm

Visicol (sodium phosphate monobasic monohydratde, USP and sodium
phosphate dibasic anhydrous, USP) Tablets, InKine Pharmaceutical
Company, Inc., posted 9/22/2000

Astelin (azelastine hydrochloride) Nasal Spray, Wallace Laboratories ,
posted 9/21/2000

Carisoprodl Tablets USP, Corepharma LLC, posted 9/21/2000

Propofol Injectable Emulsion, Gensia Sicor Pharmaceuticals, Inc., posted
9/21/2000

Amoxicillin Capsules USP, Teva Pharmaceuticals, posted 9/19/2000

Paclitaxel Injection, Mylan Pharmaceuticals, Inc., posted 9/19/2000

Pemoline Tablets, Watson Laboratories Inc., posted 9/19/2000

Kaletra (lopinavir), Abbott Laboratories, posted 9/18/2000

Qvar Inhalation Aerosol (beclomethasone dipropionate HFA 40 mcg and 80
mcg), 3M Pharmaceuticals, posted 9/18/2000



Drug Information
-------------------------------------------------
(9/7/2000)
Drug Shortages (9/7/2000)
http://www.fda.gov/cder/drug/shortages/default.htm

Warning and Untitled Letters-2000 (9/8/2000)
http://www.fda.gov/cder/warn/warn2000.htm

Approved Drug Products with Therapeutic Equivalence Evaluations-20th
Edition (Cumulative Supplement-7) (9/5/2000)
http://www.fda.gov/cder/orange/supplement/cspreface.htm
 [Information and Data Files] (9/5/2000)
http://www.fda.gov/cder/orange/obreadme.htm

Approved Drug Products with Therapeutic Equivalence Evaluations Monthly
Additions and Deletions (July 2000) (9/5/2000)
http://www.fda.gov/cder/rxotcdpl/pdpl_200007.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 (Updated 9/5/2000)
http://www.fda.gov/cder/approval/index.htm

Atacand (candesartan cilexetil - hydrochlorothiazide) Tablets,
AstraZeneca LP, posted 9/5/2000

Fluoxetine Hydrochloride Oral Solution, Novex Pharma, posted 9/5/2000

Top

Drug Information
-------------------------------------------------
(8/30/2000)
Rapamune updated 8/30/2000
http://www.fda.gov/cder/consumerinfo/druginfo/rapamune.htm

Drug Shortages (8/30/2000)
http://www.fda.gov/cder/drug/shortages/default.htm

FDA Drug Approvals List (8/29/2000)
http://www.fda.gov/cder/da/da.htm

Generic Drug Approvals (9/1/2000)
http://www.fda.gov/cder/ogd/approvals/default.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 (Updated 9/1/2000)
http://www.fda.gov/cder/approval/index.htm

Rapamune (sirolimus) Tablets, Wyeth-Ayerst, posted 8/28/2000

Desmopressin Acetate Injection, Abbott Laboratories, posted 8/29/2000

Lac-Hydrin Cream, Westwood Squibb, posted 8/29/2000

Paclitaxel Injection, Baker Norton Pharmaceuticals, Inc., posted
8/29/2000

Hydroxyurea Tablets USP, Barr Laboratories, posted 8/30/2000

Propranolol Hydrochloride Injection USP, Bedford Laboratories, posted
8/30/2000

Cipro (Ciprofloxacin Hydrochloride) Tablets, IV Solution, IV in 5%
Dextrose, IV in 0.9% Saline, & Oral Suspension, Bayer Corporation,
Pharmaceutical Division, posted 8/31/00

Arimidex (anastrozole) Tablets, AstraZeneca Pharmaceuticals, posted
9/1/00

Renova (tretionin) Cream, Johnson and Johnson Consumer Industries, Inc.,
posted 9/1/00

Top



Drug Information
-------------------------------------------------
(8/24/2000)
Drug Information Page (8/24/2000)
http://www.fda.gov/cder/drug/default.htm
Unithroid (8/22/2000)
http://www.fda.gov/cder/drug/infopage/unithroid/unithroid.htm
Lotronex (8/24/2000)
http://www.fda.gov/cder/drug/infopage/lotronex/lotronex.htm

Drug Shortages (8/25/2000)
http://www.fda.gov/cder/drug/shortages/default.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 (Updated 8/25/2000)
http://www.fda.gov/cder/approval/index.htm

Advair Diskus, Glaxo Wellcome., posted 8/25/2000

Azulfidine EN-tabs (sulfasalazine) Tablets, Pharmacia & Upjohn, posted
8/23/2000

Enalaprilat Injection, Abbott Laboratories, posted 8/23/2000

Enalaprilat Injection, Bedford Laboratories, posted 8/23/2000

Enalaprilat Injection, Faulding Pharmaceutical Co., posted 8/23/2000

Enalaprilat Injection, Gensia Sicor Pharmaceuticals, Inc., posted
8/23/2000

Enalapril Maleate Tablets USP, Eon Labs Manufacturing, Inc., posted
8/23/2000

Enalapril Maleate Tablets USP, Danbury Pharmacal, Inc., posted 8/23/2000

Enalapril Maleate Tablets USP, Par Pharmaceuticals Inc., posted
8/23/2000

Enalapril Maleate Tablets USP, Chelsea Laboratories, Inc., posted
8/23/2000

Enalapril Maleate Tablets USP, Ranbaxy Laboratories Ltd., posted
8/23/2000

Enalapril Maleate Tablets USP, Apothecon Inc., A Bristol-Myers Squibb
Co., posted 8/23/2000

Enalapril Maleate Tablets USP, Mylan Pharmaceuticals Inc., posted
8/23/2000

Enalapril Maleate Tablets USP, Wockhardt Americas Inc., posted 8/23/2000

Enalapril Maleate Tablets USP, Geneva, posted 8/23/2000

Enalapril Maleate Tablets USP, Lek Pharmaceutical & Chemical Company
d.d., posted 8/23/2000

Enalapril Maleate Tablets USP, Zenith Goldline Pharmaceuticals Inc.,
posted 8/23/2000

Loratadine Tablets, Teva Pharmaceuticals USA, posted 8/23/2000

NIMOTOP (nimodipine) Capsules, Bayer Corporation Pharmaceutical
Division, posted 8/23/2000

Quixin (levofloxacin ophthalmic solution) Sterile, Santen Incorporated,
posted 8/23/2000

Unithroid (levothyroxine sodium) Tablets USP, Jerome Stevens
Pharmaceuticals, Inc., posted 8/22/2000

Nortriptyline Hydrochloride Oral Solution USP, Pharmaceutical Associates
Inc., posted 8/24/2000

Tamiflu Page (updated 8/25/2000)
http://www.fda.gov/cder/drug/infopage/tamiflu/default.htm

Relenza Page (updated 8/21/2000)
http://www.fda.gov/cder/news/relenza/default.htm

 



Drug Information
-------------------------------------------------
(8/18/2000)
FDA Drug Approvals List (8/18/2000)
http://www.fda.gov/cder/da/da.htm

FDA Consumer Magazine: September-October 2000 (8/16/2000)
http://www.fda.gov/fdac/500_toc.html

New and Generic Drug Approvals [Includes Drug Label and Approval
Letter]  (Updated 8/17/2000)
http://www.fda.gov/cder/approval/index.htm

Certrotide (cetrorelix acetate) Injection, Asta Medica, Inc., posted
8/15/2000

Vivelle, Novartis, posted 8/17/2000

Pulmicort (budesonide inhalation suspension) Respules, AstraZeneca LP,
posted 8/17/2000

Warning and Untitled Letters-2000 (8/17/2000)
http://www.fda.gov/cder/warn/warn2000.htm

 



Drug Information
-------------------------------------------------
Updated 8/11/2000
FDA Drug Approvals List (8/11/2000)
http://www.fda.gov/cder/da/da.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 (Updated 8/8/2000)
http://www.fda.gov/cder/approval/index.htm

Depakote ER (divalproex sodium extended-release) Tablets, Abbott
Laboratories, posted 8/8/00

Top


Drug Information
-------------------------------------------------
Updated 8/4/2000
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 (Updated 8/4/2000)
http://www.fda.gov/cder/approval/index.htm

Buspirone Hydrochloride Tablets USP, KV Pharmaceutical, Co., posted
8/4/2000

Concerta (methylphenidate HCI) Extended-release Tablets, Alza Corp.,
posted 8/3/2000

Levobunolol Hydrochloride Ophthalmic Solution USP, Novex Pharma, posted
8/3/2000

Renova (tretionin) Cream, Johnson and Johnson Consumer Industries, Inc.,
posted 8/3/2000

Rescula (unoprostone isopropyl) Ophthalmic Solution, Ciba Vision, posted
8/3/2000

CellCept, Hoffman La-Roche, posted 8/1/2000

Children's Motrin Suspension (ibuprofen / pseudoephedrine suspension),
McNeil Consumer Healthcare, posted 8/1/2000

Etodolac Extended-Release Tablets, Whitney Pharmaceuticals, Inc., posted
8/1/2000

Etodolac Extended-Release Tablets, Teva Pharmaceuticals, posted 8/1/2000

Glucovance (glyburide and metformin) Tablet, Bristol-Myers Squibb,
posted 8/1/2000

Etodolac Capsules, Torpharm, posted 7/31/00

Warning and Untitled Letters-2000 (8/2/2000)
http://www.fda.gov/cder/warn/warn2000.htm

 

Top


Drug Information
-------------------------------------------------
7/28/2000

Approved Drug with Therapeutic Equivalence Evaluations (Orange Book
Query)  (Updated 7/28/2000)
http://www.fda.gov/cder/ob/default.htm

Approved Drug Products with Therapeutic Equivalence Evaluations-20th
Edition (Cumulative Supplement-6) (7/28/2000)
http://www.fda.gov/cder/orange/supplement/cspreface.htm
[Information and Data Files] (7/28/2000)
http://www.fda.gov/cder/orange/obreadme.htm

Approved Drug Products with Therapeutic Equivalence Evaluations Monthly
Additions and Deletions (June 2000) (7/28/2000)
http://www.fda.gov/cder/rxotcdpl/pdpl_200006.htm

FDA Drug Approvals List (7/28/2000)
http://www.fda.gov/cder/da/da.htm

Consumer Drug Information Page (7/25/2000)
http://www.fda.gov/cder/consumerinfo/default.htm

Labeling Review Branch (7/25/2000)
http://www.fda.gov/cder/ogd/rld/labeling_review_branch.html

Drug Shortages (7/26/2000)
http://www.fda.gov/cder/drug/shortages/default.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 (Updated 7/28/2000)
http://www.fda.gov/cder/approval/index.htm

Vaniqa (eflornithine hydrochlorine) Cream, Bristol-Myers Squibb, posted
7/28/2000

Terazosin Hydrochloride Capsules, Invamed Inc., posted 7/28/2000

Cefazolin for Injection USP & Dextrose Injection USP, B. Braun Medical
Inc., posted 7/27/2000

Famotidine Tablets USP, Reddy-Cheminor Inc., posted 7/27/2000

Pemoline Chewable Tablets, Amide Pharmaceutical, Inc., posted 7/27/2000

Doxazosin Mesylate Tablets, Torpharm, posted 7/26/00

Doxazosin Mesylate Tablets, Zenith Goldline, posted 7/26/00

Hydrocodone Bitartrate and Acetaminophen Tablets USP, 2.5 mg/500 mg; 7.5
mg/500 mg; 7.5 mg/650 mg; and 10 mg/650 mg,  Barr Laboratories Inc.,
7/26/00

Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/325 mg 10
mg/325 mg per tablet,  Mallinckrodt, Inc., 7/26/00

Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/500 mg and
7.5 mg/750 mg, Barr Laboratories, Inc., posted 7/26/00

Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, Barr
Laboratories, Inc., posted 7/26/00

Hydrocortisone Lotion USP, Altana, Inc., posted 7/25/00

Baycol (cerivastatin) Tablets, Bristol-Myers Squibb, posted 7/24/00

Doxazosin Mesylate Tablets, Teva Pharmaceuticals Inc., posted 7/24/00

Minoxidil Topical Solution USP, L. Perrigo Company, posted 7/24/00

Nifedipine Extended-release Tablets, Biovail Laboratories Inc., posted
7/24/00

Warning and Untitled Letters-2000 (7/24/2000)
http://www.fda.gov/cder/warn/warn2000.htm

 



Drug Information
-------------------------------------------------
(7/20/2000)

Drug Shortages (7/20/2000)
http://www.fda.gov/cder/drug/shortages/default.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 (Updated 7/19/2000)
http://www.fda.gov/cder/approval/index.htm

Colazal (balsalazide disodium) Capsules, Salix Pharmaceuticals, Inc.,
posted 7/19/2000

ChloraPrep (Chlorhexidine Gluconate 2% (w/v) and Isopropyl Alcohol 70%
(v/v)) One-Step, Medi-Flex Hospital Products, Inc., posted 7/17/2000

Innohep (tinzaparin sodium) Injection, Dupont Pharmaceutical Company,
posted 7/17/2000

Warning and Untitled Letters-2000 (7/18/2000)
http://www.fda.gov/cder/warn/warn2000.htm

 

Top


Drug Information
-------------------------------------------------
(7/14/2000)

FDA Approves Malarone for the Prevention and Treatment of Malaria
(7/14/2000)
http://www.fda.gov/bbs/topics/ANSWERS/ANS01026.html

Generic Drug Approvals (7/13/2000)
http://www.fda.gov/cder/ogd/approvals/default.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 (Updated 7/14/2000)
http://www.fda.gov/cder/approval/index.htm

Malarone (atovaquone and proguanil hydrochloride) Tablets, Glaxo
Wellcome Inc., posted 7/14/00

Renagel Tablets, GelTex Pharmaceuticals, posted 7/13/00

Sotalol Hydrochloride Tablets, Watson Laboratories, Inc., posted 7/13/00

Drug Shortages (7/14/2000)
http://www.fda.gov/cder/drug/shortages/default.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 (Updated 7/12/2000
http://www.fda.gov/cder/approval/index.htm

Norvasc (amlodipine besylate) Tablets, Pfizer, posted 7/12/00

Approved Drug with Therapeutic Equivalence Evaluations (Orange Book
Query)  (Updated 7/10/2000)
http://www.fda.gov/cder/ob/default.htm

Approved Drug Products with Therapeutic Equivalence Evaluations-20th
Edition (Cumulative Supplement-5) (7/10/2000)
http://www.fda.gov/cder/orange/supplement/cspreface.htm
[Information and Data Files] (7/10/2000)
http://www.fda.gov/cder/orange/obreadme.htm

Approved Drug Products with Therapeutic Equivalence Evaluations Monthly
Additions and Deletions (May 2000) (7/10/2000)
http://www.fda.gov/cder/rxotcdpl/pdpl_200005.htm

FDA Drug Approvals List (7/10/2000)
http://www.fda.gov/cder/da/da.htm

Recall: Nationwide Recall of SangCya Oral Solution (7/10/2000)
http://www.fda.gov/bbs/topics/ANSWERS/ANS01025.html

Warning and Untitled Letters-2000 (7/14/2000)
http://www.fda.gov/cder/warn/warn2000.htm

Top


Drug Information
-------------------------------------------------
(Updated 7/8/2000)

FDA Approves Fluoxetine to Treat Premenstrual Dysphoric Disorder
(7/7/2000) http://www.fda.gov/bbs/topics/ANSWERS/ANS01024.html

FDA Oncology Tools Press Release (7/7/2000)
http://www.fda.gov/bbs/topics/NEWS/NEW00731.html

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 (Updated 7/6/2000)
http://www.fda.gov/cder/approval/index.htm
Cefoxitin Injection, Americal Pharmaceutical Partners, Inc., posted
7/3/2000
Sarafem (Fluoxetine HC1) Capsules, Lilly, posted 7/6/00

Paragraph IV Patent Certifications (7/3/2000)
http://www.fda.gov/cder/ogd/ppiv.htm

Regulatory Information
-------------------------------------------------
Electronic Regulatory Submissions and Review (7/7/2000)
http://www.fda.gov/cder/regulatory/ersr/default.htm

National Drug Code Directory (7/6/2000)
http://www.fda.gov/cder/ndc/index.htm

OGD Suitability Tracking Reports  (Sorted by Drug Name) (as of
6/27/2000, Posted 7/3/2000)
http://www.fda.gov/cder/ogd/drugsort.pdf

OGD Suitability Tracking Reports  (Sorted by Petition Number) (as of
6/27/2000, Posted 7/3/2000)
http://www.fda.gov/cder/ogd/numbersort.pdf

Patent Term Extension and New Patents Docket Number *95S-0117
(7/7/2000) http://www.fda.gov/cder/orange/docket.pdf

Combined Oral Contraceptives - Labeling for Healthcare Providers and
Patients [HTML] or [Acrobat] (Issued 7/2000, Posted 7/7/2000)
http://www.fda.gov/cder/guidance/2448dft.htm
http://www.fda.gov/cder/guidance/2448dft.pdf

Warning and Untitled Letters-2000 (7/6/2000)
http://www.fda.gov/cder/warn/warn2000.htm
CDER Calendar
-------------------------------------------------

Drug Information Association Annual Meeting - San Diego, June 2000
(7/3/2000)
http://www.fda.gov/cder/present/dia-62000/default.htm

CERTs and the FDA Implementation of FDAMA 409 (7/3/2000)
http://www.fda.gov/cder/present/dia-62000/certsd/index.htm

Periodic Safety Updates: Opportunities and Challenges - A U.S.
Perspective (7/3/2000)
http://www.fda.gov/cder/present/dia-62000/diapsu/index.htm

Update from the Office of Postmarketing Drug Risk Assessment (7/3/2000)
http://www.fda.gov/cder/present/dia-62000/opdra/index.htm

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(Updated 6/30/2000)
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 http://www.fda.gov/cder/approval/index.htm

ACOVA (argatroban) Injection, Texas Biotechnology Corporation, posted
6/30/2000

Amiodarone Hydrochloride Tablets, Eon Labs Manufacturing, Inc., posted
6/30/2000

Betaxolol Ophthalmic Solution USP, Akorn, Inc., posted 6/30/2000

Doxycycline Capsules USP, Eon Labs Manufacturing Inc., posted 6/30/2000

Enalapril Maleate Tablets USP, Teva Pharmaceuticals, posted 6/30/2000

Midazolam Hydrochloride Injection, Taylor Pharmaceuticals, posted
6/30/2000

Nolvadex (tamoxifen citrate) Tablets, Astra Zeneca Pharmaceuticals,
posted 6/30/2000

Compro (Prochlorperazine) Suppositories USP, Paddock Laboratories, Inc.,
posted 6/29/2000

Enalapril Maleate Tablets USP, Eon Labs Manufacturing, Inc., posted
6/29/2000

Tamoxifen Citrate Tablets USP, Novopharm Limited, posted 6/28/2000

Targretin (bexarotene) Gel, Ligand Pharmaceuticals, posted 6/28/2000

Bleomycin for Injection USP, Gensia Sicor Pharmaceuticals, Inc., posted
6/27/2000

Midazolam Hydrochloride Injection, Astra Pharmaceuticals, L.P., posted
6/27/2000

Midazolam Hydrochloride Injection, Bedford Laboratories, posted
6/27/2000

Pravachol (Pravastatin) Tablets, Bristol-Myers Squibb, posted 6/27/2000

Tamoxifen Citrate Tablets USP, Mylan Phrmaceuticals Inc., posted
6/27/2000

 



(Updated 6/21/2000)
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 http://www.fda.gov/cder/approval/index.htm

Genotropin (somatropin [rDNA origin] ) Injection, Pharmacia & Upjohn
Co., posted 6/21/2000

Midazolam Hydrochloride Injection, Abbott Laboratories, posted 6/21/2000

Midazolam Hydrochloride Injection, Aesgen, Inc., posted 6/21/2000

Midazolam Hydrochloride Injection, Baxter Pharmaceutical Products, Inc.,
posted 6/21/2000

Midazolam Hydrochloride Injection, Ben Venue Laboratories, Inc., posted
6/21/2000

Midazolam Hydrochloride Injection, ESI Lederle, Inc., posted 6/21/2000

Midazolam Hydrochloride Injection, Faulding Pharmaceutical Co., posted
6/21/2000

Norditropin (somatropin [rDNA origin] injection) Cartridges, Novo
Nordisk Pharmaceuticals, Inc., posted 6/21/2000

Taxol (paclitaxel) Injection, Bristol-Myers Squibb, posted 6/21/2000

 

Top


(6/19/2000)
FDA Drug Approvals List
http://www.fda.gov/cder/da/da.htm

New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 (Updated 6/19/2000)
http://www.fda.gov/cder/approval/index.htm

Isosorbide Mononitrate Extended-release Tablets, Zenith Goldline
Pharmaceuticals, Inc., posted 6/19/2000



(Updated 6/14/2000)
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 http://www.fda.gov/cder/approval/index.htm

Meperidine Hydrochloride Tablets USP, Mallinckrodt Inc., posted
6/14/2000

Vecuronium Bromide for Injection, Bedford Laboratories, posted 6/14/2000



(Updated 6/12/2000)
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 http://www.fda.gov/cder/approval/index.htm

Pravachol (pravastatin)Tablets, Bristol-Myers Squibb, posted 6/12/2000



(Updated 6/9/2000)
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 http://www.fda.gov/cder/approval/index.htm

Fludeoxyglucose F-18 Injection, Downstate Clincal PET Center - The Meth.
Med. Ctr. of IL., posted 6/9/2000

NovoLog (insulin aspart [rDNA origin]) Injection, Novo Nordisk, posted
6/9/2000

Promethazine Hydrochloride Injection USP, Abbott Laboratories, posted
6/9/2000

Nabumetone Tablets, Copley Pharmaceutical, Inc., posted 6/6/2000
(Updated 6/9/2000)
St. John's Wort Public Health Advisory
http://www.fda.gov/cder/drug/advisory/stjwort.htm

 



(Updated 6/6/2000)
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 http://www.fda.gov/cder/approval/index.htm

Nabumetone Tablets, Copley Pharmaceutical, Inc., posted 6/6/2000


(Updated 6/1/2000)
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 http://www.fda.gov/cder/approval/index.htm

Hydrocodone Bitartrate and Acetaminophen Tablets, Vintage
Pharmaceuticals Inc., posted 6/1/2000


(Updated 5/30/2000)
New and Generic Drug Approvals cludes Drug Label and Approval Letter
http://www.fda.gov/cder/approval/index.htm

DIFFERIN (adapalene) Cream, Galderma, L.P., posted 5/30/2000

Olux (clobetasol propionate) Foam, Connectics Corporation, posted 5/30/2000

Welchol (colesevelam hydrochloride), GelTex Pharmaceuticals, posted 5/30/2000

 


(Updated 5/25/2000)
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 (Updated 5/25/2000
http://www.fda.gov/cder/approval/index.htm

Enalaprilat Injection, Bedford Laboratories, posted 5/25/2000

Ursodiol Capsules USP, Copley Pharmaceutical, Inc.5/25/2000

 



(Updated 5/24/2000)
New and Generic Drug Approvals [Includes Drug Label and Approval
Letter]
http://www.fda.gov/cder/approval/index.htm

Buspirone Hydrochloride Tablets USP, Par Pharmaceutical, Inc., posted
5/24/2000

Buspirone Hydrochloride Tablets USP, Geneva Pharmaceuticals, Inc.,
posted 5/24/2000

Buspirone Hydrochloride Tablets USP, ESI Lederle, posted 5/24/2000

Buspirone Hydrochloride Tablets USP, Novopharm Limited, posted 5/24/2000

Gonal-F (follitropin alfa) Injection, Serono Laboratories, posted
5/24/2000

Hydrocortisone Valerate Cream USP, Clay-Park Labs, Inc., posted
5/24/2000

 



(Updated 5/23/2000)
New and Generic Drug Approvals [Includes Drug Label and Approval Letter]
 http://www.fda.gov/cder/approval/index.htm
OPTIVAR (azelastine hydrochloride ophthalmic solution), ASTA Medica,
Inc., posted 2/23/2000

 



May 22, 2000
Center for Drug Evaluation and Research: What's New
Today's new material on the CDER website...

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