Another FDA approval in Glenmark's kitty

Glenmark Pharmaceuticals receives ANDA approval for Diclofenac Sodium Gel, 3%


Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Diclofenac Sodium Gel, 3%, the generic version of Solaraze® Gel, 3% of Fougera Pharmaceuticals Inc. According to IMS Health sales data for the 12 month period ending July 2016, the Solaraze® Gel, 3% market1 achieved annual sales of approximately $297.9 million. Glenmark’s current portfolio consists of 110 products authorized for distribution in the U.S. marketplace and 61 ANDA’s pending approval with the U.S. 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.

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