Strides gets USFDA nod for Oxybutynin Chloride Tablets

Strides Pharma Science announced that its step-down wholly-owned subsidiary, Strides Pharma Global, Singapore, has received approval for Oxybutynin Chloride Tablets USP, 5 mg from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Ditropan Tablets, 5 mg, of Janssen Pharmaceuticals.

Oxybutynin Chloride Tablets belongs to a class of drugs known as antispasmodics. The medication is used to treat overactive bladder and urinary conditions. It relaxes the muscles in the bladder  to help decrease problems of urgency and frequent urination.

According to IQVIA MAT October 2020 data, the US market for Oxybutynin Chloride Tablets USP, 5 mg is approximately $29 million. The product will be manufactured at the company’s flagship facility at Bengaluru and will be marketed by Strides Pharma in the US market.

The company has 127 cumulative ANDA filings with USFDA of which 94 ANDAs have been approved and 33 are pending approval.