Hyderabad-based, Aurobindo Pharma Limited has received the tentative approval from the US Food & Drug Administration (FDA) to manufacture and market its anti-AIDS combination drug efavirenz/ emtricitabine and tenofovir disoproxil fumarate tablets, 600mg/ 200mg/ 300mg. Aurobindo is the first generics company to receive this approval.

Efavirenz/ emtricitabine and tenofovir disoproxil fumarate tablets, 600mg/ 200mg/ 300mg is the generic equivalent of Gilead Sciences Inc.’s Atripla tablets 600mg/ 200mg/ 300mg and falls under the antiretroviral (ARV) segment. It is indicated in combination with other ARV agents for the treatment of HIV-1 infection in adults. This ANDA was reviewed under the expedited provisions of the President’s Emergency Plan for AIDS relief (PEPFAR).

Aurobindo now has a total of 182 ANDA approvals (156 final approvals including two from Aurolife Pharma LLC and 26 tentative approvals) from US FDA.

Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients (APIs).