Strides Arcolab Limited has received a tentative approval from the US Food and Drug Administration (FDA) for its anti AIDS combination drug Tenofovir Disoproxil Fumarate and Emtricitabine tablets, 300mg and 200mg.
The Company is one among the six generics companies to have received US FDA approval. This abbreviated new drug application (ANDA) has been reviewed under the expedited provisions of the President’s Emergency Plan for AIDS relief (PEPFAR). The company supplies ARV products to global procurement agencies and this approval adds to the overall basket of medicines available.
The combination drug: Tenofovir Disoproxil Fumarate and Emtricitabine is the generic equivalent of Gilead Sciences Inc’s Truvada tablets and falls under the anti-retroviral (ARV) segment. It is indicated in combination with other anti-retroviral agents for the treatment of HIV-1 infection in adults.
Bengaluru-based Strides Arcolab, develops and manufactures a wide range of IP-led niche pharmaceutical products with an emphasis on sterile injectables. The company has 14 manufacturing facilities across six countries with presence over 75 countries in developed and emerging markets. It also has a global R&D Centre manned by 350-scientists.