The drug is used to treat symptoms of overactive bladder and urinary incontinence
Strides Pharma Science said its Singapore-based arm has received approval from the US health regulator for generic Oxybutynin Chloride tablets used to treat symptoms of overactive bladder and urinary incontinence.
Company’s 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 (US FDA), Strides said in a filing to BSE.
The product is a generic version of Janssen Pharmaceuticals’ Ditropan tablets in the same strength, it added.
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, Strides said.
“According to IQVIA MAT October 2020 data, the US market for Oxybutynin Chloride tablets USP, 5 mg is approximately $29 million”, it added.
The company has 127 cumulative abbreviated new drug application (ANDA) filings with US FDA of which 94 ANDAs have been approved and 33 are pending approval, the filing said.