FDA tentative appro of three-component AIDS drug

The US Food and Drug Administration has issued the first tentative approval for a three-ingredient, fixed-dose tablet for use as a stand-alone antiretroviral treatment for HIV-1 infection in adults. The product contains the active ingredients in the widely-used antiretroviral drugs Epivir (lamivudine and Retrovir (zidovudine), both made by GlaxoSmithKline, and Viramune (nevirapine), from Boehringer Ingelheim.

The agency's tentative clearance means that, although existing patents and/or exclusivity prevent approval of this product in the USA, it meets all of the FDA's manufacturing quality and clinical safety and efficacy standards required for marketing in the country. The fixed-dose combination tablet, manufactured by Aurobindo Pharma of Hyderabad, India, will be available for purchase and distribution in 15 developing countries under the President's Emergency Plan for AIDS Relief (PEPFAR).