Glenmark receives tentative ANDA approval for generic Vesicare Tablets

22 Jun 2017 Evaluate

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (USFDA) for Solifenacin Succinate Tablets, 5 mg and 10 mg, the generic version of Vesicare Tablets, 5 mg and 10 mg of Astellas Pharma US Inc.

According to IMS Health sales data for the 12 month period ending April 2017, the Vesicare Tablets, 5 mg and 10 mg market achieved annual sales of approximately $1.1 billion.

Glenmark’s current portfolio consists of 117 products authorized for distribution in the US marketplace and 68 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.


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