Updated April 22nd, 2024 at 15:24 IST

Zydus Lifesciences surges on US FDA approval for overactive bladder drug

Approval marks a milestone for Zydus, positioning it among the early suppliers to introduce the generic version of Mirabegron Extended-Release Tablets.

Reported by: Business Desk
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Ahmedabad-based pharmaceutical company, Zydus Lifesciences, witnessed a surge in its shares, soaring up to 4.70 per cent to hit an intraday high of Rs 965.60. The boost followed an announcement from the company regarding the approval granted by the United States Food and Drug Administration (USFDA) for its Mirabegron Extended-Release Tablets USP 25 mg and 50 mg, aimed at treating overactive bladder (OAB) symptoms.

The approval marks a milestone for Zydus Lifesciences, positioning it among the early suppliers to introduce the generic version of Mirabegron Extended-Release Tablets, USP 25 mg, in the US market. The company is set to soon launch the Mirabegron Extended-Release Tablets, 50mg.


Mirabegron, indicated for OAB treatment, addresses symptoms such as urge urinary incontinence, urgency, and urinary frequency. Manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ, the drug's approval reflects Zydus Lifesciences' commitment to enhancing healthcare accessibility.

Dr. Punit Patel, CEO Americas at Zydus, expressed satisfaction with the launch, stressing its potential to improve patient access and availability of the generic product in the US market. The launch aligns with the company's growth strategy for the current fiscal year, further solidifying its position in the US pharmaceutical market.


Mirabegron Extended-Release Tablets USP 25mg and 50mg recorded annual sales of $2.42 billion in the US, according to IQVIA MAT February 2024 data. With this approval, Zydus Lifesciences adds to its robust portfolio, boasting 393 approvals and over 460 filed ANDAs since the commencement of the filing process in FY 2003-04.

As of 2:15 pm, Zydus Lifesciences shares traded 4 per cent higher at Rs 959.40, outperforming the Sensex which was up 0.7 per cent.


Published April 22nd, 2024 at 15:24 IST