Mylan Inc today said its Indian subsidiary Matrix Laboratories had received tentative approval from the US health regulator for its new drug application for generic Lamivudine, Tenofovir Disoproxil Fumarate tablets, used for treatment of AIDS/HIV.
Matrix Laboratories has received approval for Lamivudine, Tenofovir Disoproxil Fumarate tablets in the strengths of 300 mg co-packaged with Nevirapine tablets in the strength of 200 mg, Mylan said in a statement.
"The approval of Lamivudine, Tenofovir Disoproxil Fumarate tablets co-packaged with Nevirapine tablets is an important product developed by Matrix for the treatment of HIV/AIDS," Mylan President Heather Bresch said.
The product will be eligible for purchase outside the US in certain developing countries, the company said.
The tentative approval from the US Food and Drug Administration (USFDA) is through the President's Emergency Plan for AIDS Relief (PEPFAR), it added.
