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From: ButtGaser
Date: 6/21/2002
Time: 7:25:47 PM
Remote Name: 12.245.42.248
Hi, no Dutasteride/Avolve/Duagen/Dutasteride/or GI198745 here-
June 21, 2002
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. Angiomax (bivalirudin) Injection, The Medicines Company Cenestin (synthetic conjugated estrogens, A) Tablets, Barr Laboratories, Inc. Crixivan (Indinavir Sulfate) Capsules, Merck Research Laboratories Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, CorePharma LLC Dopamine Hydrochloride and 5% Dextrose Injection, USP, Baxter Healthcare Corporation Geodon (Ziprasidone Mesylate) Injection, Pfizer, Inc. Isovue (iopamidol injection) and Isovue Multipack (iopamidol injection-pharmacy bulk pack), Bracca Diagnostics Inc. Lotrel (amlodipine and benazepril HCl) Capsules, Novartis Pharmaceuticals Corporation Ophthetic (proparacaine HCl ophthalmic solution), Allergan, Inc. Serzone (nefazodone hydrochloride) Tablets, Bristol-Myers Squibb Company Skelaxin (metaxalone) Tablets, Elan Pharmaceuticals, Inc. Tramadol Hydrochloride Tablets, Caraco Pharmaceutical Laboratories, Ltd. Tramadol Hydrochloride Tablets, Purepac Pharmaceutical Co. Tramadol Hydrochloride Tablets, Teva Pharmaceuticals Tramadol Hydrochloride Tablets, CorePharma LLC Tramadol Hydrochloride Tablets, Mutual Pharmaceutical Co. Tramadol Hydrochloride Tablets, Mylan Pharmaceuticals, Inc. Wellbutrin (bupropion hydrochloride) Immediate-Release & Sustained-Release Tablets, Glaxo SmithKline
June 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 Drug Shortages http://www.fda.gov/cder/drug/shortages/default.htm Current Drug Shortage: Amidate (Etomidate Injection) 2 mg/mL http://www.fda.gov/cder/drug/shortages/default.htm#Current Pediatric Exclusivity Statistics as of May 1, 2002 http://www.fda.gov/cder/pediatric/wrstats.htm Spectrum of Diseases/Conditions Written Requests as of May 1, 2002 http://www.fda.gov/cder/pediatric/specdis.htm
June 19, 2002
Bar Code Label Requirements for Human Drug Products; Notice of Public Meeting. Meeting on July 26, 2002. [HTML] http://www.fda.gov/OHRMS/DOCKETS/98fr/061802a.htm or [PDF] http://www.fda.gov/OHRMS/DOCKETS/98fr/061802a.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 New and Generic Drug Approvals [Includes Drug Label and Approval Letter] http://www.fda.gov/cder/approval/index.htm Alphagan (brimonidine tartrate ophthalmic solution), 0.5, 0.2 & (P) 0.15%, Drug Approval Package Betapace (sotalol hydrochloride) Tablets, Drug Approval Package Infuvite Pediatric (Multiple Vitamins for Infusion) IV, Drug Approval Package Levo-T (levothyroxine sodium tablets, USP), Drug Approval Package Navelbine (Vinorelbine) Injection, Drug Approval Package Tequin (Gatifloxacin) Tablets & Injection, Drug Approval Package
June 18, 2002
Evaluation of Written Prescription Information Provided in Community Pharmacies, 2001. http://www.fda.gov/cder/reports/prescriptionInfo/default.htm New and Generic Drug Approvals [Includes Drug Label and Approval Letter] http://www.fda.gov/cder/approval/index.htm Aggrastat (tirofiban hydrochloride) Injection & Premixed Injection, Merck & Co., Inc. Colazal (balsalazide disodium) Capsules, Salix Pharmaceuticals, Inc. Doryx (coated doxycycline hyclate pellets) Capsules, F. H. Faulding & Co, Ltd. Lanoxin (digoxin) Injection, GlaxoSmithKline Monodox (doxycycline monohydrate) Capsules, Watson Laboratories, Inc. Vibramycin Monohydrate (doxycycline monohydrate) Oral Suspension, Vibramycin Capsules, Intravenous, Vibramycin Calcium (doxycycline calcium oral suspension) Syrup, Vibra-Tabs (doxycycline hyclate) Film Coated Tablets, Pfizer, Inc. Nonprescription Drugs Advisory Committee Roster http://www.fda.gov/cder/audiences/acspage/nonprescriptionroster1.htm Warning Letters and Notice of Violation Letters to Pharmaceutical Companies http://www.fda.gov/cder/warn/warn2002.htm
June 17, 2002
Office of Generic Drugs Approvals http://www.fda.gov/cder/ogd/approvals/AP0502.htm First-Time Generics http://www.fda.gov/cder/ogd/approvals/1stgen0502.htm Tentative Approvals http://www.fda.gov/cder/ogd/approvals/TA0502.htm Paragraph IV Drug Patent Certifications http://www.fda.gov/cder/ogd/ppiv.htm Office Directory http://www.fda.gov/cder/ogd/ogddir.htm 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 Safety and Risk Management Committee Charter (Updated) http://www.fda.gov/cder/audiences/acspage/DSaRMcharter.htm Patent Term Extension and New Patents Docket Number *95S-0117 http://www.fda.gov/cder/orange/docket.pdf Studies Breakdown Report for Issued Written Requests as of 6/1/2002: Pediatric Exclusivity http://www.fda.gov/cder/pediatric/breakdown.htm
All of you should have a subscription to this CDER Weekly- It is how I first found out that Dutasteride was FDA approved. However, I'm not sure if it deals with sNDA's at all, but be sure to pay close attention to this detail- Tentative Approvals http://www.fda.gov/cder/ogd/approvals/TA0502.htm
-ButtGaser
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