Mumbai: Matrix Laboratories has received tentative approval from the US Food and Drug Administration (FDA) for its tenofovir disoproxil fumarate tablets, used for the treatment of HIV infection.
The company''''s abbreviated new drug application (ANDA) tenofovir tablets will be available in the strength of 300 mg, it said in a filing with the Bombay Stock Exchange (BSE).
Tenofovir disoproxil fumarate is the first and only generic tentative approval of Gilead Sciences Inc''''s Viread Tablets of 300 mg. Tenofovir disoproxil fumarate would help meet the need for high quality, affordable treatment in the developing world, where the prevalence of HIV/AIDS is high, Matrix said ion its filing.
The FDA approval, granted under the US President''''s Emergency Plan for AIDS Relief (PEPFAR), allows Matrix to immediately sell an HIV or AIDS treatment outside the United States.
Existing patents and marketing exclusivity prevent the approval of the product in the United States. The approval was the seventh PEPFAR tentative approval within the last 12 months.