Glenmark Generics secures final USFDA approval for Montelukast Sodium tablets

Glenmark Generics Inc., USA a subsidiary of Glenmark Generics has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (USFDA) for Montelukast Sodium tablets, 10mg. The company will commence distribution of the product immediately.

Montelukast Sodium tablets are Glenmark’s generic version of Singulair by Merck & Company, Inc., indicated for the treatment of prophylaxis and chronic treatment of asthma. According to IMS Health, for the 12 month period ending March 2012, Singulair garnered annual sales of $3.5 billion.

Glenmark’s current portfolio consists of 81 products authorized for distribution in the US marketplace and 39 ANDA’s pending approval with the USFDA. 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.

Glenmark Generics is a subsidiary of Glenmark Pharmaceuticals (Glenmark) and aims to be a global integrated Generic and API leader. GGL has an established presence in North America, a developing EU presence and Argentina and maintains marketing front-ends in these countries.