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Mylan unit steps up in HIV fight.

PITTSBURGH -- Mylan Inc. announced this spring that Matrix Laboratories Ltd., the India-based subsidiary in which it holds a 71.2% controlling interest, has received the first tentative approval from the Food and Drug Administration under the President's Emergency Plan for AIDS Relief for its abbreviated new drug application for emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg.

"This product approval is yet another important step in providing access to a range of critical HIV medications to patients in developing countries," says Mylan vice chairman and chief executive officer Robert Coury. "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 antiretroviral franchise."

Emtricitabine and tenofovir disoproxil fumarate tablets are the genetic version of Gilead Sciences Inc.'s Truvada tablets. Truvada 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' antiretroviral products include active pharmaceutical ingredients and first- and second-line finished doses. The company's affordable products have driven down the average annual cost per patient of effective therapies. About 30% of HIV/AIDS patients in developing countries depend on Matrix antiretroviral drugs.

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Title Annotation:RX/Generic Drugs
Publication:Chain Drug Review
Article Type:Brief article
Date:Apr 20, 2009
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