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Zydus launched Mirabegron Exte...


Zydus launched Mirabegron Extended-Release Tablets in the US

Zydus Mirabegron Extended-Release Tablets US
The Silicon Review
23 April, 2024

The group boasts 393 approvals and has filed over 460* ANDAs since the initiation of the filing process in FY 2003-04.

Zydus Lifesciences Limited, along with its subsidiaries and affiliates, has announced the introduction of Mirabegron Extended-Release Tablets, 25 mg, into the US market. Having previously obtained final approval from the United States Food and Drug Administration (USFDA) for Mirabegron Extended-Release Tablets USP 25 mg and 50 mg (USRLD: Myrbetriq® Extended-Release Tablets), Zydus is among the pioneering suppliers to launch the generic version of Mirabegron Extended-Release Tablets USP 25 mg in the US market, with plans to soon launch the 50mg variant. Mirabegron serves as treatment for overactive bladder (OAB) symptoms, including urge urinary incontinence, urgency, and urinary frequency. The manufacturing of this drug will take place at Zydus' formulation manufacturing facility in Ahmedabad SEZ, India.

CEO Americas, Dr. Punit Patel, expressed satisfaction with the launch, highlighting its potential to enhance access and availability of the generic product for patients in the US market. He underscored the launch's significance in bolstering Zydus' growth plans in the US market for the current fiscal year. Mirabegron Extended-Release Tablets USP 25mg and 50mg garnered annual sales of USD 2.42bn in the US as per IQVIA MAT February 2024. Zydus Lifesciences Ltd., driven by its overarching purpose of empowering individuals to lead healthier and more fulfilling lives, stands as an innovative, global lifesciences company. It specializes in discovering, developing, manufacturing, and marketing a diverse range of healthcare therapies, with a notable presence in cancer-related therapies.