Glenmark Pharma receives tentative ANDA approval for solifenacin succinate tabs

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

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 authorised for distribution in the US market place 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.