Mylan's Matrix receives tentative FDA approval under PEPFAR for generic Truvada

Mar 30 2009

Mylan Inc. has announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.2% controlling interest, has received the first tentative approval from the U.S. Food and Drug Administration (FDA) 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.

Mylan Vice Chairman and CEO Robert J. Coury said: "This product approval is yet another important step in providing access to a range of critical HIV medications to patients in developing countries. Mylan and Matrix continue to make a significant contribution to bringing down the cost of these vital treatments through the expansion of our high-quality anti-retroviral franchise."

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets are the generic version of Gilead Sciences Inc.'s Truvada(R) Tablets. Truvada(R) is a second-line anti-HIV drug in the nucleoside reverse transcriptase inhibitor (NRTI or "nuke") family and is used in combination with other medications to control HIV infection. Patients often use second-line therapies if and when they develop resistance to initially prescribed treatments or experience clinical failures.

Matrix's wide range of ARV products includes active pharmaceutical ingredients (API) and first- and second-line finished doses. The company's emphasis on producing affordable products has allowed it to drive down the average annual cost per patient of effective therapies. Approximately 30% of HIV/AIDS patients in developing countries depend on Matrix ARV products.

Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest - and highest quality - product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's third largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies.