Monday, December 29, 2008

HIV/AIDS Update - Tentative Approval of Generic Emtricitabine Capsule Formulation

On December 23, 2008, FDA granted tentative approval for a generic version of emtricitabine capsules 200 mg, manufactured by Matrix Laboratories, Ltd., of Hyderabad, India, reviewed under the expedited review provisions for the President’s Emergency Plan for AIDS Relief. Emtricitabine is a Nuceloside Reverse Transcriptase Inhibitor (NRTI) indicated in combination with other antiretroviral medications for teatment of HIV infection.

The details can be read here.

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