Zydus Lifesciences on Monday said it has received the U.S. FDA's final nod to market its generic version of Mirabegron extended-release tablets used to treat overactive bladder, with 180 days of shared generic drug exclusivity.
The final approval granted by the U.S. Food and Drug Administration to the company's U.S. arm Zydus Pharmaceuticals Inc. is for the tablets of strengths 25 mg and 50 mg, it said in a regulatory filing.
Zydus was one of the first applicants to submit a substantially complete abbreviated new drugs application with a paragraph IV certification for Mirabegron extended-release tablets, 25 mg and 50 mg and is therefore eligible for 180 days of shared generic drug exclusivity for the drug, it added.
Mirabegron is indicated for the treatment of overactive bladder with symptoms of urinary incontinence, urgency and urinary frequency.
The drug will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, the filing added.
As per IQVIA MAT August 2022 data, Zydus said Mirabegron extended-release tablets 25mg and 50mg had annual sales of $2.42 billion in the U.S.
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