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Mylan's Matrix Receives Tentative FDA Approval Under PEPFAR for First Generic, Heat-Stable Version of HIV Protease Inhibitor
Date:3/12/2009

Provides first affordable protease inhibitor for patients in developing countries Complements recent WHO approval earned for the same product

PITTSBURGH, March 12 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL) today announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.5% controlling interest, has received the first and only 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 Lopinavir/Ritonavir Tablets, 200 mg/50 mg. Matrix's version of this product is heat-stable and affordable, making it practical for distribution and use in warm climates.

Mylan Vice Chairman and CEO Robert J. Coury said: "Mylan and Matrix are committed to our growing and high quality antiretroviral franchise. Our goal is to provide HIV treatments to patients around the world -- especially in developing countries. With Matrix's heat-stable and affordable version of Lopinavir/Ritonavir, patients in remote parts of developing nations will have access to this important life-saving drug. This is the second regulatory approval that this important product has recently earned, which further confirms our commitment to providing high-quality medicines at affordable prices."

Lopinavir/Ritonavir Tablets are the generic version of Abbott Laboratories' Kaletra(R) Tablets, the brand marketed in the U.S. and Europe, and Aluvia(R) Tablets, the brand marketed in developing countries. It is used in combination with other medications to control HIV infection and is included in the antiretroviral (ARV) class of drugs known as HIV protease inhibitors.

Last month, Matrix was awarded the first and only World Health Organization (WHO) approval for the same product. These approvals
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SOURCE Mylan Inc.
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