What's New on the FDA Drugs Site
November 18, 2009
Drugs@FDA Download File (updated) Medication Guides (updated) Paragraph IV Patent Certifications (updated)
New and Generic Drug Approvals
November 18, 2009
Adenosine Injection, Akorn Inc., Tentative Approval Betaxolol Ophthalmic Solution, Wockhardt Ltd., Approval Butalbital, Acetaminophen and Caffeine Capsule, NexGen Pharmaceuticals, Approval Famotidine Tablets, Ranbaxy Laboratories Ltd., Approval Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, Dr. Reddy's Laboratories Ltd., Tentative Approval Lysteda (tranexamic acid) Tablets, Xanodyne Pharmaceuticals, Inc., Approval Qutenza (capsaicin) Patch, Neurogesx, Inc., Approval Rilutek (riluzole) Tablets, Sanofi Aventis U.S., L.L.C., Labeling Revision Soma Compound (aspirin and carisoprodol) Tablets, Meda Pharmaceuticals, Inc., Labeling Revision Soma (carisoprodol) Tablets, Meda Pharmaceuticals, Inc., Labeling Revision
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