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Medical news

HIV/AIDS Drug Gains Tentative FDA Approval

October 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

Adapted from:
United Press International
10.29.2008


  
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This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.
 
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