Matrix gets tentative US FDA approval for HIV/AIDS drugs

Matrix Laboratories, a Hyderabad-based subsidiary of Mylan Inc. has received tentative approval from the US Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for efavirenz, lamivudine and tenofovir disoproxil fumarate tablets, 600 mg/300 mg/300 mg.

Mylan's product represents the first-ever fixed-dose combination of efavirenz, lamivudine and tenofovir disoproxil fumarate and now provides Matrix with numerous tenofovir combination product opportunities. This new drug adds to the Matrix portfolio of important treatments for HIV/AIDS. The product may be used for either first- or second-line treatment in adults. People use second-line therapies if and when they develop resistance to initially prescribed treatments.