Mumbai: Pharmaceutical company Matrix Laboratories Wednesday said it has received tentative approval from the US Food and Drug Administration (FDA) for 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, Matrix said in a filing to the Bombay Stock Exchange.
Matrix received the approval from US FDA under the Presidents Emergency Plan for AIDS Relief (PEPFAR), which allows it to immediately sell an HIV or AIDS treatment outside the US, the statement added.
Meanwhile, existing patents and marketing exclusivity prevent the approval of the product in the US.
The approval was the seventh PEPFAR tentative approval within the last 12 months.
Matrixs Tenofovir Disoproxil Fumarate is the first and only generic tentative approval of Gilead Sciences Incs Viread Tablets of 300 mg.
Tenofovir Disoproxil Fumarate would help to meet the need for high quality, affordable treatment in the developing world, where the prevalence of HIV/AIDS is high.
Shares of Matrix were trading at Rs225, up 2.69% on the BSE in morning trade.