Glenmark Generics has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (US FDA) for Montelukast Sodium Tablets, 10mg. Glenmark will commence distribution of the product immediately. Montelukast Sodium tablets are Glenmark’s generic version of Singulair® by Merck & Co., Inc., indicated for the treatment of prophylaxis and chronic treatment of asthma.
For the 12 month period ending March 2012, Singulair® garnered annual sales of USD 3.5 billion according to IMS Health.
EP News Bureau