Strides Pharma Science arm gets USFDA nod for drug to treat overactive bladder

Strides Pharma Science Limited (Strides) has announced that its stepdown 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 is a generic version of Vesicare Tablets, 5 mg and 10 mg, of Astellas Pharma US, Inc. According to IQVIA MAT data, the US market for Solifenacin Succinate Tablets, 5 mg and 10 mg is approximately US$ 820 Mn. The product will be manufactured at Alathur facility in Chennai and will be 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 are pending approval.

Solifenacin Succinate Tablet is an antispasmodic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.