Thursday, November 19, 2009

CDER New November 18, 2009

FDA (U.S. Food and Drug Administration)

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

  • Manage your FDA Subscriptions:


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