Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Diclofenac Sodium Gel, 3%, the generic version of Solaraze Gel, 3% of Fougera Pharmaceuticals Inc.
The Solaraze Gel, 3% market had achieved annual sales of approximately $297.9 million, according to IMS Health sales data for the twelve month period ending July 2016.
Glenmark’s current portfolio consists of 110 products authorized for distribution in the US marketplace and 61 ANDA’s pending approval with the USFDA. 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.
