Zydus receives USFDA final approval for Mirabegron extended-release tablets

3 Oct 2022 , 11:36 AM

Zydus Lifesciences Limited’s U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received final approval from the United States Food and Drug Administration (USFDA).

The USFDA approval is to market Mirabegron Extended-Release Tablets USP 25 mg and 50 mg (USRLD: Myrbetriq).

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.

As per the press release, Mirabegron is indicated for the treatment of overactive 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 SEZ, India.

Mirabegron Extended-Release Tablets USP 25mg and 50mg had annual sales of USD 2.42 billion in the United States according to IQVIA data (IQVIA MAT August 2022).

The group now has 324 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04.

At around 11:38 AM, Zydus Lifesciences Ltd is currently trading at Rs402.30 per share up by Rs15.6 or 4.03% from its previous closing of Rs386.70 per share on the BSE.

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