USFDA gives nod to Zydus Cadila’s overactive bladder tablets
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New Delhi: The US Food and Drug Administration (USFDA) has given final approval to drug firm Zydus Cadila to market oxybutynin chloride tablets used to treat symptoms of overactive bladder and urinary incontinence.
In a filing to the BSE on Wednesday, the company said it “has received the final approval from the USFDA to market oxybutynin chloride extended-release tablets in the strength of 5 mg, 10 mg, 15 mg”.
The drug is used to take care of an overactive bladder and urinary incontinence (urine leakage) and will be produced at the group’s formulation manufacturing facility at Moraiya in Ahmedabad.
The group now has over 120 approvals and so far filed over 300 ANDAs (abbreviated new drug applications) since the commencement of the filing process in 2003-04.