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Mylan's Matrix Receives Tentative FDA Approval Through PEPFAR for Novel "Co-Packaged" Version of HIV/AIDS Treatment
Date:9/20/2011

PITTSBURGH, Sept. 20, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) through the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Lamivudine / Tenofovir Disoproxil Fumarate Tablets, 300 mg/300 mg, co-packaged with Nevirapine Tablets, 200 mg. The product will be eligible for purchase outside the U.S. in certain developing countries.

(Photo:  http://photos.prnewswire.com/prnh/20110920/NE71136)

Mylan President Heather Bresch said: "The approval of Lamivudine / Tenofovir Disoproxil Fumarate Tablets co-packaged with Nevirapine Tablets is an important product developed by Matrix for the treatment of HIV/AIDS. For the first time, it makes available a co-pack option that can help patients with the carrying and storage of this critical first-line ARV cocktail. Co-packs are convenient and may help to facilitate patient compliance with what often can be part of a burdensome drug regimen for HIV/AIDS patients managing many prescriptions and therapies."

This product offering is the first generic ARV drug product in a co-pack form and can be used alone or in combination with other ARVs for the treatment of HIV/AIDS. The FDA's tentative approval through PEPFAR signifies that Matrix's product meets all of the agency's manufacturing quality, safety and efficacy standards.

Lamivudine, Tenofovir Disoproxil Fumarate and Nevirapine are the generic versions of GlaxoSmithKline's Epivir®, Gilead Sciences' Viread® and Boehringer Ingelheim's Viramune®, respectively. This particular co-pack of ARV products also is suitable for the treatment of pregnant women with HIV/AIDS in certain countries where Lamivudine, Tenofo
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SOURCE Mylan Inc.
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