Glenmark Pharmaceuticals received final approval from the United States (US) health regulator for Solifenacin Succinate tablets, used for treatment of overactive bladder, on Tuesday.
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 Bombay Stock Exchange (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 $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.