Tentative approval for a fixed-dose, three-ingredient tablet to treat HIV/AIDS

The Food and Drug Administration (FDA), on June 30, 2006, issued the first tentative approval for a fixed-dose, three-ingredient tablet for use as a complete anti-viral treatment of human immunodeficiency virus (HIV-1) infection in adults. The product, (lamivudine-zidovudine-nevirapine tablet), contains the active ingredients in the widely used antiretroviral drugs Epivir (lamivudine), Retrovir (zidovudine) and Viramune (nevirapine). The combination tablet is manufactured by Aurobindo Pharma Ltd. in Hyderabad, India.

The recommended regimen for the lamivudine-zidovudine-nevirapine tablet is one pill twice a day following an initial two week treatment with the individual components taken individually. Each ingredient of this generic tablet is currently approved to treat HIV-1 infected adults in combination with other antiretroviral agents. The safety and effectiveness of the combination of lamivudine-zidovudine-nevirapine in lowering the viral load and increasing the CD4+ cell has been demonstrated in previously conducted adequate and well controlled studies of the individual ingredients being used together for treatment.

The labeling of the combination drug includes a medication guide and a boxed warning that the drug’s use can cause liver failure, severe rash, and lactic acidosis (buildup of an acid in the blood).

Under the PEPFAR program, the FDA may grant a tentative approval if it concludes that a drug product has met all of the required clinical safety and efficacy and manufacturing quality standards for marketing in the United States. However, because of existing patents and/or exclusivity rights protecting the individual innovator products, the fixed dose combination product cannot be sold on the United States at this time.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration