Matrix Laboratories gets US health regulator nod for generic AIDS tablets

21 Sep 2011 Evaluate

Matrix Laboratories, an Indian subsidiary of Mylan Inc has received tentative approval from the US health regulator for its new drug application for generic Lamivudine, Tenofovir Disoproxil Fumarate tablets. These drugs are used for treatment of AIDS/HIV. The product will be eligible for purchase outside the US in certain developing countries.

The company has received approval for the above tablets in the strengths of 300 mg co-packaged with Nevirapine tablets in the strength of 200 mg which is an important product developed by it. The tentative approval from the US Food and Drug Administration (USFDA) is through the President's Emergency Plan for AIDS Relief (PEPFAR).

The company also offers contract research and development services for earlier stages of development and contract manufacturing for projects that have advanced further into development and are being considered for commercial manufacturing.

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