NEW DELHI: Drug firm Aurobindo Pharma has said it has received tentative approval from the US health regulator to manufacture and market its anti-AIDS combination drug Efavirenz/Emtricitabine and Tenofovir Disoproxil Fumarate tablets in the American market.
The company has received tentative approval from the US Food and Drug Administration (USFDA) for the combination drug in the strength of 600mg/200mg/300mg Aurobindo Pharma said in a statement.
The tablets are generic equivalent of Gilead Sciences Inc’s Atripla tablets in the same strength combination and fall under the anti-retroviral (ARV) segment, it added.
“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 said.
The company now has a total of 182 abbreviated new drug application (ANDA) approvals (156 final approvals, including two from Aurolife Pharma LLC and 26 tentative approvals) from USFDA, it added.-PTI
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