Matrix Laboratories Limited, a subsidiary of Mylan Ind, has received the first tentative approval from the US Food and Drug Administration under the President's Emergency Plan for AIDS Relief for its abbreviated new drug application for Emtricitabine and Tenofovir Disoproxil Fumarate tablets, 200 mg /300 mg.
These two are the generic version of Gilead Sciences Inc's Truvada tablets, which are used in combination with other medications to control HIV infection.
Matrix chairman Robert J Coury said that the new approval was a step towards providing access to a range of critical HIV medications.
Matrix anti retroviral products include active pharmaceutical ingredients and first and second line finished doses. About 30 per cent of HIV/AIDS patients in developing countries depend on Matrix anti retroviral products, the company stated a release said.