Strides Pharma gets USFDA nod for generic version of Vesicare Tablets to treat overactive bladder
"Solifenacin Succinate Tablet is a generic version of Vesicare Tablets, 5 mg and 10 mg, of Astellas Pharma US, Inc, " Strides Pharma said.
Bangalore: Drugmaker Strides Pharma Science Limited (Strides) today announced 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).
Solifenacin Succinate Tablet is an antispasmodic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
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 are 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.