Strides Pharma secures USFDA okay for Oxybutynin Chloride Tablets
The medication is used to treat overactive bladder and urinary conditions.
Bengaluru: Strides Pharma Science Limited has recently announced that the company's 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. The company has 127 cumulative ANDA filings with USFDA of which 94 ANDAs have been approved and 33 are pending approval.
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.
The Company's global manufacturing sites are located in India‐ Bangalore (two locations), Pondicherry, and Chennai, Singapore, Italy‐ Milan, Kenya‐ Nairobi and United States‐Florida.