Matrix Laboratories has got the first tentative nod from the US Food and Drug Administration (USFDA) under the President’s Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg.
The tablets are the generic version of Gilead Sciences Inc.’s Truvada Tablets.
The company considers the product approval to be an additional important step in providing access to a range of critical HIV medications to patients in developing countries. Mylan and the company have continued to make a major contribution to bringing down the cost of these vital treatments through the expansion of their high-quality anti-retroviral franchise.