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U.S. Centers for Disease Control and Prevention
• Medical news
HIV/AIDS Drug Gains Tentative FDA ApprovalOctober 30, 2008 The Food and Drug Administration on Wednesday granted tentative approval to generic lamivudine, which will enable the AIDS drug’s use in the President’s Emergency Plan for AIDS Relief. The drug, marketed by Macleods Pharmaceuticals Ltd. of India, is the 75th generic antiretroviral FDA has approved under an expedited program for PEPFAR. FDA noted that existing patents preclude US market approval of generic lamivudine. Tentative approval means the drug meets FDA’s normal quality, safety, and efficacy standards and is eligible for purchase through PEPFAR. Back to other news for October 2008 United Press International 10.29.2008 This article was provided by U.S. Centers for Disease Control and Prevention. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.
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