Strides Arcolab Limited (Strides) announced today that it has received tentative approval from the United States Food and Drug Administration for abbreviated new drug application (ANDA) for Abacavir Sulfate Tablets, 300mg under the expedited review provisions of the President’s Emergency Plant for AIDS Relief (PEPFAR).
The company supplies ARV products to global procurement agencies and this approval adds to the overall basket of medicines available.
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 6 countries with presence in more than 75 countries in developed and emerging markets.