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Drug firm Strides Pharma Science on Friday 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 Pte Ltd, Singapore, has received approval for Oxybutynin Chloride Tablets USP, 5 mg from the United States Food & Drug Administration (USFDA), Strides stated in a filing to BSE.
The product is a generic version of Janssen Pharmaceuticals Inc’s Ditropan pills in precisely the same strength, it included.
“Based on IQVIA MAT October 2020 data, the US market for Oxybutynin Chloride tablets USP, 5 mg is approximately $29 million”, it added.
The business has 127 cumulative abbreviated new drug application (ANDA) filings with USFDA of which 94 ANDAs have been approved and 33 are pending approval, the filing stated.
At 3.25 pm, shares of Strides Pharma Science were trading at Rs 776.25 on BSE, up 0.67 percent from its previous close.
