May 21, 2008-On May 9, 2008, FDA granted tentative approval for a generic formulation of emtricitabine capsules, 200 mg, manufactured by Aurobindo Pharma Limited, Hyberdad, India, for use in combination with other antiretrovirals in the treatment of HIV infection. The application was reviewed under expedited review provisions for the President's Emergency Plan for AIDS Relief (PEPFAR[http://www.pepfar.gov/ ]), and represents the first tentative approval of a generic formulation of emtricitabine.
The details can be read here.
No comments:
Post a Comment