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Strides Arcolab Limited today announced that it has received tentative approval from the US FDA for its anti aids combination drug Tenofovir Disoproxil Fumarate and Emtricitabine Tablets, 300mg and 200mg.
The combination drug is the generic equivalent of Gilead Sciences Inc’s Truvada 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.
The company is one among the 6 generics companies to have received US FDA approval. This abbreviated new drug application (ANDA) has been reviewed under the expedited provisions of the President’s Emergency Plan for AIDS relief (PEPFAR).
The company supplies ARV products to global procurement agencies and this approval adds to the overall basket of medicines available, a company statement said.
