Glenmark Pharma Gets USFDA Nod For Overactive Bladder Treatment Drug

Glenmark Pharmaceuticals has received final approval from the US health regulator for Solifenacin Succinate tablets, used for treatment of overactive bladder.

The approved product is a generic version of Vesicare tablets of Astellas Pharma US, Inc.

Glenmark Pharmaceuticals Inc, USA, has been granted final approval by the United States Food and Drug Administration (USFDA) for Solifenacin Succinate tablets in the strengths of 5 mg and 10 mg,” the company said in a BSE filing.

Quoting IQVIA sales data for the 12 month period ending March 2019, Glenmark Pharma said the Vesicare tablets, 5 mg and 10 mg market achieved annual sales of approximately USD 942.7 million.

The company’s current portfolio consists of 154 products authorised for distribution at the US marketplace and 58 abbreviated new drug applications (ANDAs) pending approval with the USFDA. – Tribune India