FDA Gives Tentative Approval of Three-Drug AIDS Regimen
Tablet will be manufactured in India and distributed in 15 non-U.S. countries
THURSDAY, July 6 (HealthDay News) -- The U.S. Food and Drug Administration has issued the first tentative approval of a three-in-one, fixed-dose tablet as a stand-alone antiretroviral treatment for HIV-1 in adults. The product contains the active ingredients in the widely used drugs lamivudine (Epivir), zidovudine (Retrovir) and nevirapine (Viramune).
Although existing patents or exclusivity prevent approval in the United States, the agency determined the product meets all manufacturing quality, and clinical safety and efficacy standards that are required for marketing in the United States. The tablet, which is made by Aurobindo Pharma Ltd. in Hyderabad, India, will be distributed in 15 other countries under the President's Emergency Plan for AIDS Relief (PEPFAR).
"Today's approval marks a significant step forward in our commitment to clearing the way to quickly deliver quality, life-saving HIV/AIDS drugs to people who desperately need them in developing countries," said Michael Leavitt, U.S. Secretary of Health and Human Services, in a statement.
The recommended regimen for the tablet is one pill twice a day following an initial two-week treatment with the individual drugs taken separately. Each ingredient in this combination is currently approved to treat HIV-1 infected adults in combination with other antiretroviral agents.