Strides receives USFDA approval for Oxybutynin Chloride Tablets
Posted On:
2020-12-18 02:41:57
(Time Zone: Arizona, USA)
Strides Pharma Science Limited (Strides) today announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, 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, Inc.
According to IQVIA MAT October 2020 data, the US market for Oxybutynin Chloride Tablets USP, 5 mg is approximately US$ 29 Mn. The product will be manufactured at the company's flagship facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.