Glenmark Pharma gets US FDA tentative ANDA approval for rufinamide tablets USP

New Delhi, May 21, 2015
Glenmark Pharmaceuticals Inc., USA (Glenmark) has received tentative approval from US FDA for its rufinamide tablets USP, 200 mg and 400 mg, a therapeutic equivalent of Banzel tablets of Eisai, Inc.

Under the terms of a settlement agreement between Glenmark and Eisai, Glenmark will be permitted to market this product in the United States on May 30, 2022 or potentially earlier under certain circumstances.

According to IMS Health sales data for the 12 month period ending March 2015, the Banzel market achieved annual sales of approximately $121.8 million.

Glenmark’s current portfolio consists of 96 products authorized for distribution in the US marketplace and 68 ANDA’s pending approval with the US FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.