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Wednesday, September 21, 2011

Mylan's Indian arm Matrix Labs gets tentative approval from USFDA for AIDS tablets

 Matrix Laboratories, the Indian arm of drugmaker Mylan Inc, has received the tentative approval from the US Food and Drug Administration (USFDA) to market its generic Lamivudine, Tenofovir Disoproxil Fumarate tablets, used for treatment of AIDS/HIV.
Under the granted approval, Matrix Laboratories is permitted to market Lamivudine, Tenofovir Disoproxil Fumarate tablets in the strengths of 300 mg co-packaged with Nevirapine tablets in the strength of 200 mg.
Mr Heather Bresch, Mylan President, 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.”
Mr Robert J Coury, Mylan Vice Chairman and CEO, said, “This product approval is yet another important step in providing access to a range of critical HIV medications to patients in developing countries. 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 anti-retroviral franchise.”
The company secured the tentative approval from the US Food and Drug Administration (USFDA) through the President's Emergency Plan for AIDS Relief (PEPFAR).

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