Aurobindo Pharma has received tentative approval from the US Food & Drug Administration (USFDA) to manufacture and market its anti-AIDS combination drug Efavirenz / Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 600mg/200mg/300mg.
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 Anti-Retroviral (ARV) segment. It is indicated in combination with other antiretroviral 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 2 from Aurolife Pharma LLC and 26 Tentative approvals) from USFDA.
