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www.fdanews.com/articles/88076-aurobindo-s-hiv-aids-combination-treatment-gets-tentative-approval

AUROBINDO'S HIV/AIDS COMBINATION TREATMENT GETS TENTATIVE APPROVAL

July 3, 2006

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.