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 drugs use in the Presidents 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 FDAs normal quality, safety, and efficacy standards and is eligible for purchase through PEPFAR.
United Press International