Matrix Laboratories has informed us that it has received tentative approval from the U.S. FDA under the president’s emergency plan for AIDS relief (PEPFAR) for its ANDA for tenofovir disoproxil fumarate tablets, 300 mg. The company’s tenofovir disoproxil fumarate is the first and only generic tentative approval of Gilead Sciences Inc.’s viread tablets, 300 mg.
The company’s ANDA was tentatively approved in less than six months and is the seventh PEPFAR tentative approval earned by the company within the last 12 months. Under PEPFAR, a tentative approval means that a company can immediately sell an HIV / AIDS treatment outside of the United States. Although existing patents / 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.
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.