The US Food and Drug Administration has tentatively approved a three-ingredient, fixed-dose tablet, developed by Indian drugmaker Aurobindo Pharma, 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 manufacturing, quality and safety standards have been met for the product, although it cannot be fully approved because its composition contains ingredients that are still patented. Combined sales of the three ingredients are around $5 billion a year.
However, the fixed-dose combination will be available for purchase and distribution in 15 developing countries under the President's Emergency Plan for AIDS Relief (PEPFAR), and could make highly-active antiretroviral therapy (HAART) more affordable in countries where the need for treatment is greatest.