Glenmark gets USFDA nod for Montelukast Sodium tablet
Glenmark today said that its subsidiary Generics Inc., has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (US FDA)for Montelukast Sodium tablets, 10 mg.
Montelukast Sodium tablets are Glenmark s generic version of Singulair¬ by Merck and Co. indicated for the treatment of prophylaxis and asthma.
For the 12 month period ending March 2012, Singulair¬ garnered annual sales of USD 3.5 billion according to IMS Health.
Glenmark s current portfolio consists of 81 products authoriSed for distribution in the U.S. marketplace and 39 ANDA s pending approval with the U.S. FDA, the company informed BSE.