-----Original Message-----
From: U.S. Food & Drug Administration (FDA)
Sent: 11/16/2011 3:30:04 PM
To: guyperea@live.com
Subject: CDER New November 15, 2011
What's New on the FDA Drugs Site
November 15, 2011
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (ZIP - 378KB)
- Drug Shortages: Current Drug Shortages: Amphetamine Mixed Salts Immediate-Release Tablets (updated)
- Drug Shortages: Current Drug Shortages: Bleomycin Injection (updated)
- Drug Shortages: Current Drug Shortages: Calcitriol 1 mcg/mL Injection (updated)
- Drug Shortages: Current Drug Shortages: Dexamethasone Injection (updated)
- Drug Shortages: Current Drug Shortages: Doxorubicin Solution for Injection (updated)
- Drug Shortages: Current Drug Shortages: Fosphenytoin Sodium Injection (updated)
- Drug Shortages: Current Drug Shortages: Haloperidol Decanoate Injection (updated)
- Drug Shortages: Current Drug Shortages: Neostigmine methylsulfate injection (updated)
- Drug Shortages: Current Drug Shortages: Vasopressin Injection (updated)
- FDA/PhUSE Annual Computational Science Symposium, March 19-20, 2012, Silver Spring Civic Center, Silver Spring, MD. Meeting information and registration
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
New and Generic Drug Approvals
November 15, 2011
- Azor (amlodipine besylate and olmesartan medoxomil) Tablets, Daiichi Sankyo Inc., Labeling Revision
- Cordarone (amiodarone hydrocholride) Tablets, Wyeth Pharmaceuticals Inc., Labeling Revision
- Lanoxin (digoxin) Injection, GlaxoSmithKline LLC, Labeling Revision
- Lanoxin (digoxin) Tablets, GlaxoSmithKline LLC, Labeling Revision
- Mytelase (ambenonium chloride) Tablets, sanofi-aventis U.S., LLC, Labeling Revision
- Olopatadine Hydrochloride Ophthalmic Solution, Apotex Corp., Tentative Approval
- Tarka (trandolapril and verapamil hydrochloride) Tablets, Abbott Laboratories, Labeling Revision
- Tekamlo (aliskiren hemifumarate and amlodipine besylate) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Treximet (naproxen sodium and sumatriptan succinate) Tablets, GlaxoSmithKline, Labeling Revision
- Twynsta (amlodioine besylate and telmisartan) Tablets, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
- Verelan (verapamil hydrochloride) Extended-Release Capsules, Alkermes Gainesville LLC, Labeling Revision
- Verelan PM (verapamil hydrochloride) Extended-Release Capsules, Alkermes Gainesville LLC, Labeling Revision
- Zolinza (vorinostat) Capsules, Merck Research Laboratories, Labeling Revision
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