FDA Grants Tentative Approval to Generic Atripla

Aurobindo Pharma Ltd. April 3 announced that it has received tentative approval from the Food and Drug Administration to market a generic version of Gilead Sciences Inc.'s Atripla (efavirenz/emtricitabine and tenofovir disoproxil fumarate) 600 mg/200 mg/300 mg tablets.

Atripla is indicated in combination with other antiretroviral agents for treating HIV-1 infection in adults, the company said.

Aurobindo, which is based in Hyderabad, India, said the abbreviated new drug application (ANDA) for the product was reviewed under the President’s Emergency Plan for AIDS Relief (PEPFAR). The approval under PEPFAR means that the product will be eligible for purchase outside the United ...