Aurobindo Pharma Ltd 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.
The Hyderabad-based company was one of the first generics companies to have received this approval, according to a release.
The 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.
"This Abbreviated New Drug Application (ANDA) was reviewed under the expedited provisions of the President’s Emergency Plan for AIDS relief (PEPFAR)," the company said.