Glenmark Pharma’s gets USFDA nod for Solifenacin Succinate tablets

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Mumbai, June 30, 2017: Pharma Major Glenmark Pharmaceuticals today said that 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, Solifenacin Succinate tablets are used for treatment of overactive bladder, company said in a filing with BSE. 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 Abbreviated New Drug Applications (ANDA) pending with the USFDA

United News of India