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The US Food and Drug Administration (USFDA) has given final approval to Zydus Cadila to market oxybutynin chloride tablets used to treat overactive bladder and urinary incontinence.
In a filing to the BSE today, 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 treat 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.
Shares of Cadila Healthcare were trading up by 0.3 per cent at Rs 527.10 on the BSE.
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