Mumbai, Sep 27 : Pharma Major, Strides Pharma Science Limited on Friday said that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Solifenacin Succinate Tablets, 5 mg and 10 mg from the United States Food & Drug Administration (USFDA).
The product was a generic version of Vesicare Tablets, 5 mg and 10 mg, of Astellas Pharma US, Inc, the company said in a filing with BSE. According to IQVIA MAT data, the US market for Solifenacin Succinate Tablets, 5 mg and 10 mg was approximately US$ 820 Mn. The product would be manufactured at Alathur facility in Chennai and marketed by Strides Pharma Inc. in the US market.
The company has 102 cumulative ANDA filings with USFDA of which 66 ANDAs have been approved and 36 were pending approval. Solifenacin Succinate Tablet was an antispasmodic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. (UNI)