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Mylan's Matrix Receives First and Only Tentative FDA Approval Under PEPFAR for Generic Version of Atripla HIV Treatment
Mylan, 08/19/09
Mylan Inc. announced that Matrix Laboratories, an Indian company in which Mylan owns a controlling stake, has received tentative approval from the U.S. Food and Drug Administration under the President's Emergency Plan for AIDS Relief for its Abbreviated New Drug Application for a fixed–dose combination of Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Tablets, 600 mg/200 mg/300 mg. This is the first and only generic version of this product and will be eligible for purchase outside the U.S. in many developing countries.
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