FDA grants tentative approval to Aurobindo HIV drug

Generic version of Atripla given tentative approval under PEPFAR program

HYDERABAD, India — The Food and Drug Administration has given preliminary approval to a drug made by Aurobindo Pharma for treating HIV infection in developing countries, the drug maker said.

Aurobindo announced that it had received tentative approval for efavirenz/emtricitabine/tenofovir disoproxil fumarate combination tablets in the 600-mg/200 mg/300-mg strength. The drug is a generic version of Gilead Sciences' Atripla.

Tentative approval means that the drug meets the FDA's requirements for approval, but the agency can't give it final approval because the branded drug's patent protection hasn't expired. The tentative approval was given under the President's Emergency Plan for AIDS Relief, or PEPFAR, which aims to provide low-cost HIV medications to people in poor countries.

 

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