Aurobindo Pharma gets USFDA nod for anti-AIDS drug

The combination drug is the generic equivalent of Gilead Sciences Inc's Atripla Tablets and falls under the anti-retroviral segment

Hyderabad-based Aurobindo Pharma Limited has received tentative approval to manufacture and market its anti-AIDS combination drug Efavirenz / Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 600mg, 200mg and 300mg from the US Food & Drug Administration (USFDA).

According to an Aurobindo press release, it is one of the first generics company to have received USFDA approval for anti-AIDS drug. This abbreviated new drug application (ANDA) has been reviewed under the expedited provisions of the President’s Emergency Plan for AIDS relief (PEPFAR).

The combination drug is the generic equivalent of Gilead Sciences Inc’s  Atripla Tablets and falls under the anti-retroviral (ARV) segment. It is indicated in combination with other anti-retroviral agents for the treatment of HIV-1 infection in adults.  

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