FDA APPROVES GENERIC COMBIVIR FOR PEPFAR USE

The FDA has granted Indian drugmaker Aurobindo Pharma tentative approval to manufacture fixed-dose combination lamivudine and zidovudine tablets for use outside the U.S.

The tablets are the generic version of GlaxoSmithKline's Combivir tablets and contain 150 mg of lamivudine and 300 mg of zidovudine in each tablet. Aurobindo Pharma's combination product will be made available for consideration for purchase under President Bush's Emergency Plan for AIDS Relief. Lamivudine and zidovudine are nucleoside reverse transcriptase inhibitors, which aid in prohibiting the AIDS virus from reproducing. The combination product is indicated to be used in conjunction with other antiretroviral agents for treatment of HIV-1 infection.