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Tuesday, May 18, 2010 2:37:04 PM
Link : http://www.fda.gov/Drugs/NewsEvents/UCM130961
New and Generic Drug Approvals
Visit Drugs@FDA1 to search Drug Approval Reports by Month.
May 18, 2010
Lamivudine and Stavudine2 Tablets, Hetero Drugs Ltd., Tentative Approval
Retrovir3 (zidovudine) Capsules, GlaxoSmithKline, Labeling Revision
Retrovir4 (zidovudine) Syrup, GlaxoSmithKline, Labeling Revision
Retrovir5 (zidovudine) Tablets, GlaxoSmithKline, Labeling Revision
Savella6 (milnacipran hydrochloride) Tablets, Cypress Bioscience, Inc., Labeling Revision
May 17, 2010
Afinitor7 (everolimus) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
Alprazolam8 Extended-Release Tablets, Watson Laboratories, Approval
Bicalutamide9 Tablets, Fresenius Kabi Oncology, Approval
Invega Sustenna10 (paliperidone palmitate) Extended-Release Intramuscular Suspension, Ortho-McNeil-Jansen Pharmaceuticals, Inc., Labeling Revision
Letrozole11 Tablets, Fresenius Kabi Oncology, Tentative Approval
Letrozole12 Tablets, Accord Healthcare, Inc., Tentative Approval
Taxotere13 (docetaxel) Injection, Sanofi-Aventis U.S., Inc., Efficacy Supplement with Clinical Data to Suppport
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