Mylan's Matrix Receives First and Only Tentative FDA Approval Under PEPFAR for Generic Version of Atripla(R) HIV...( PITTSBURGH Aug. 18 ...),Health

PITTSBURGH, Aug. 18 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL) today 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 (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for a fixed-dose combination (FDC) 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.

Mylan President Heather Bresch said: "This critical approval only further strengthens Mylan and Matrix's efforts to expand access to life-saving, affordable AIDS treatments for people living with HIV/AIDS in developing countries. Matrix's generic fixed-dose combination will dramatically improve access to this more patient-friendly medication while reducing the cost of treatment. Our commitment to growing Matrix's ARV (antiretroviral) franchise goes hand-in-hand with our desire to raise the standard of care in developing countries to the levels available in countries like the U.S."

The Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate FDC is the generic version of Gilead Sciences' Atripla(R) Tablets, which are indicated 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 developed countries, with approximately $1.6 billion in U.S. sales alone for the twelve months ending June 30, according to IMS Health. Until now, a generic version of this product has not been available in any market. Cocktails co
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