New Delhi: Glenmark Pharmaceuticals said the US health regulator has granted tentative approval for tablets used for treatment of overactive bladder.
The company has been granted tentative approval by the United States Food and Drug Administration (USFDA) for Solifenacin Succinate tablets, 5 mg and 10 mg, Glenmark Pharmaceuticals said in a BSE filing.
The company’s products are the generic version of Vesicare tablets, 5 mg and 10 mg of Astellas Pharma US Inc.
According to IMS Health April 2017 sales data, the market for Vesicare tablets, 5 mg and 10 mg, saw annual sales of approximately USD 1.1 billion.
Glenmark’s current portfolio consists of 117 products authorised for distribution in the US marketplace, the company said, adding that it has 68 ANDAs pending approval with the USFDA.