Glenmark Generics, USA the subsidiary of Glenmark Generics, has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (US FDA) for Riluzole tablets, 50 mg. The company will commence shipping immediately. Riluzole is indicated for the treatment of amyotrophic lateral sclerosis. Based on IMS Health sales data for the 12 month period ending March 2013, Riluzole garnered sales of $64 million.
Glenmark’s current portfolio consists of 86 products authorised for distribution in the US marketplace and 52 ANDA’s pending approval with the US FDA. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.
EP News Bureau – Mumbai