The US Food and Drug Administration (FDA) has received Zydus’s Mirabegron extended-release tablets USP 25 mg and 50 mg, according to a statement from Zydus Lifesciences.
Mirabegron is indicated for the treatment of Over Active Bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad, the statement notified.
It further said that Zydus was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Mirabegron extended-release tablets, 25 mg and 50 mg, and, therefore, is eligible for 180 days of shared generic drug exclusivity for Mirabegron extended-release tablets, 25 mg and 50 mg.
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