Matrix Laboratories, a Hyderabad-based manufacturer of active pharmaceutical ingredients (APIs), has received tentative approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for tenofovir disoproxil fumarate tablets in 300 mg form.Matrix's tenofovir disoproxil fumarate is the first and the only generic tentative approval of Gilead Sciences Inc's Viread tablets 300 mg. The company received this approval under the President's Emergency Plan for AIDS Relief (PEPFAR), according to a press release issued today.The ANDA was tentatively approved in less than six months and is the seventh PEPFAR tentative approval earned by it within the last 12 months, it added.Under PEPFAR, a tentative approval means that a company can immediately sell an HIV/AIDS treatment outside of the US.Although existing patents or marketing exclusivity prevent the approval of the product in the US, a tentative approval indicates that the product meets all safety, efficacy and manufacturing quality standards for marketing in the US, which helps to ensure AIDS patients abroad who receive these medications get the same quality product as the American public.
