Glenmark Pharma receives ANDA approval for nitroglycerin sublingual tablets

IMS Health estimates annual sales of approx $112.7 million for these three strenghts of Nitrostat® Sublingual Tablets

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (US FDA) for Nitroglycerin Sublingual Tablets USP, 0.3 mg, 0.4 mg, and 0.6 mg, the generic version of Nitrostat® Sublingual Tablets, 0.3 mg, 0.4 mg, and 0.6 mg, of Pfizer, Inc.

According to IMS Health sales data for the 12 month period ending July 2017, the Nitrostat® Sublingual Tablets, 0.3 mg, 0.4 mg, and 0.6 mg market achieved annual sales of approximately $112.7 million. Glenmark’s current portfolio consists of 125 products authorised for distribution in the US marketplace and 61 ANDAs pending approval with the US FDA.