Aurobindo Pharma receives US FDA tentative approval for anti-AIDS combination drug

Aurobindo Pharma has received US Food and Drug Administration (US FDA) tentative approval 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 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 two from Aurolife Pharma and 26 tentative approvals) from US FDA.

EP News Bureau – Mumbai