FDAnews Drug Daily Bulletin

FDA GIVES TENTATIVE APPROVAL TO AUROBINDO'S COMBINATION ARV

July 12, 2006
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The FDA has granted tentative approval to a three-ingredient fixed-dose tablet for use as a stand-alone HIV-1 antiretroviral (ARV) treatment. The product, manufactured by Indian drugmaker Aurobindo Pharma, contains the active ingredients from the ARVs Epivir (lamivudine), Retrovir (zidovudine) and Viramune (nevirapine).

This combination has been shown to be safe and effective in lowering the viral load in HIV-1-infected patients. The recommended regimen for the product involves taking one pill twice daily, following an initial two-week treatment in which each of the components is taken individually.

If approved, the combination treatment will be available for distribution in the U.S. and 15 other countries under the President's Emergency Plan for AIDS Relief (PEPFAR), launched in 2003. The initiative aims to provide $15 billion in HIV/AIDS prevention and treatment programs by 2008.