FDA Approves PEPFAR For Tenofovir Disoproxil Fumarate Tablets

Armen Hareyan's picture
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Matrix Laboratories has received tentative approval from FDA for its Abbreviated New Drug Application (ANDA) for Tenofovir Disoproxil Fumarate Tablets, 300 mg. Matrix's Tenofovir Disoproxil Fumarate is the first and only generic tentative approval of Gilead Sciences Inc.'s Viread Tablets, 300 mg.

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Matrix's ANDA was tentatively approved in less than six months and is the seventh PEPFAR tentative approval earned by Matrix within the last 12 months. Under PEPFAR, a tentative approval means that a company can immediately sell an HIV/AIDS treatment in certain countries outside of the United States. Although existing patents and/or marketing exclusivity prevent the approval of the product in the United States, a tentative approval indicates that the product meets all safety, efficacy and manufacturing quality standards for marketing in the United States, which helps to ensure AIDS patients abroad who receive these medications get the same quality product as the American public.

Mylan Vice Chairman and CEO Robert J. Coury said: "This is yet another milestone for Mylan and Matrix and their commitment to the Company's growing antiretroviral (ARV) franchise that includes active pharmaceutical ingredients (API) and finished dosage forms for first- and second-line treatments. We applaud Matrix for its high quality science and manufacturing capabilities that resulted in earning this important tentative approval in such a short timeframe. Tenofovir Disoproxil Fumarate will help to meet the urgent and increasing need for high quality, affordable treatment in the developing world where the prevalence of HIV/AIDS is socially and economically devastating."

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