Glenmark gets US FDA nod for Solifenacin Succinate Tablets

The US FDA approved the Abbreviated New Drug Application for Solifenacin Succinate Tablets, 5 mg and 10 mg, which are a generic version of Vesicare Tablets

Glenmark has been granted final approval by the United States Food & Drug Administration (US FDA) for Solifenacin Succinate Tablets, 5 mg and 10 mg, a generic version of Vesicare Tablets, 5 mg and 10 mg, of Astellas Pharma US, according to a press release issued by the company.

“According to IQVIATM sales data for the 12 month period ending March 2019, the Vesicare Tablets, 5 mg and 10 mg market achieved annual sales of approximately $942.7 million”, the press release stated.

Glenmark’s current portfolio consists of 154 products authorized for distribution in the US marketplace and 58 Abbreviated New Drug Application’s (ANDA) 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, added the press release.