Wednesday, May 21, 2008

FDA Update, 5/20/2008

New and Generic Drug Approvals

acetaminophen, caffeine and dihydrocodeine bitartrate Capsules, E5 Pharma, Inc., Manufacturing Revision
Butorphanol Tartrate Preservative Free Injection, Apotex Corp., Control Supplement
Emtriva (emtricitabine) Oral solution and capsules, Gilead Sciences, Inc., Efficacy Supplement with Clinical Data to Support - For HIV
Norvir (ritonavir) capsules and oral solution, Abbott Laboratories, Labeling Revision
Tekturna (aliskiren hemifumarate) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
Truvada (emtricitabine and tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Efficacy Supplement with Clinical Data to Support
Viread (tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Efficacy Supplement with Clinical Data to Support

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