HIV Update - Approval of fixed dose tablet containing lamivudine/zidovudine 150 mg/300 mg

Information about FDA HIV-related product approvals, safety warnings, notices of upcoming public meetings, and notices about proposed regulatory guidances. 

FDA recently granted approval for a fixed dose combination tablet containing 2 nucleoside analogue reverse transcriptase inhibitors, lamivudine/zidovudine 150 mg/300 mg, indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents. 

Please note that this product formulation must be taken on an empty stomach as compared to COMBIVIR and other generic formulations that can be taken without regard to food.

Product labeling for this formulation of lamivudine and zidovudine is available at Drugs@FDA.

The tablet, manufactured by Pharmacare Limited of South Africa, was Tentatively Approved by FDA on 08/23/2006 for use outside the United States under the PEPFAR program.

Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration