Yesterday, Mylan Inc. (
MYL) announced that its Indian subsidiary, Matrix Laboratories, received tentative approval from the US Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its generic version of a fixed-dose combination of Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate tablets in 600 mg/200mg/300 mg dosage strengths.
The decision is in response to an Abbreviated New Drug Application filed by the Indian subsidiary. The tentative approval under PEPFAR is indicative of the fact that the product satisfies all the manufacturing quality, safety and efficacy standards laid down by the agency.
The Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate combination is the generic version of Gilead Sciences’ (GILD) Atripla tablets used for the treatment of HIV-1 infection in adults. It combines three anti-AIDS medicines into a single, daily dose for either first- or second-line treatment and is one of the best-selling AIDS products in
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