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Mylan Inc.

Mylan Receives Tentative FDA Approval Under PEPFAR for Matrix Laboratories' New Drug Application NDA for Efavirenz Tablets

Published in AIDS Weekly, January 4th, 2010

Mylan Inc. (NASDAQ:MYL) announced that its subsidiary Matrix Laboratories Limited 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 New Drug Application (NDA) for Efavirenz Tablets, 50 mg, 100 mg and 200 mg. These innovative pediatric dosages in tablet form were developed by Matrix for use in treating pediatric HIV/AIDS.

Mylan President Heather Bresch commented: "This New Drug Application represents another successful innovation by Matrix in the fight against HIV/AIDS. Our HIV/AIDS antiretroviral (ARV) franchise continues to grow and to bring more affordable, high...

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