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Mylan Receives Tentative FDA Approval Through PEPFAR for First Heat-Stable, Fixed-Dose Combination of Atazanavir Sulfate and Ritonavir Tablets for HIV/AIDS
Date:12/1/2011

PITTSBURGH, Dec. 1, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Laboratories Limited (formerly 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 Atazanavir Sulfate and Ritonavir Tablets, 300 mg/100 mg.

This product is the first heat-stable, fixed-dose combination of Atazanavir Sulfate and Ritonavir, an antiretroviral (ARV) used to treat HIV/AIDS. It also has been "prequalified" by the World Health Organization (WHO) as a second-line treatment option and can be used in combination with other ARVs for the treatment of HIV/AIDS. It will be eligible for purchase outside the U.S. in certain developing countries; it also will be a significant addition to Mylan's ARV portfolio in India, which is expected to become available during the second quarter of 2012.

Mylan President Heather Bresch said: "The approval of this fixed dose product is a groundbreaking development for the treatment of second-line HIV/AIDS patients. For the first time, it makes available a generic antiretroviral (ARV) drug with Atazanavir Sulfate and Ritonavir in a fixed-dose combination tablet. This 'combo' helps to facilitate treatment compliance for HIV/AIDS patients by providing a convenient, once-a-day dosing option, while reducing the cost of treatment for patients. The approval is representative of Mylan's continued commitment to providing critical life-saving therapies to people living with HIV/AIDS around the world."

The FDA's tentative approval through PEPFAR signifies that Mylan's product meets all of the agency's manufacturing quality, safety and efficacy standards. Atazanavir and Ritonavir are the generic versions of Bristol-Myers Squibb's Reyataz® and Abbott Laboratories' Norvir&
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SOURCE Mylan Inc.
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