Mirabegron Extended-Release Tablets will strengthen growth plans in US market, says Dr Patel
Zydus Lifesciences Limited has launched Ahmedabad-made Mirabegron Extended-Release Tablets, 25 mg in the US market following approval by the United States Food and Drug Administration (USFDA) https://www.fda.gov/ .
The approval allows marketing of Mirabegron Extended-Release Tablets USP 25 mg and 50 mg (USRLD: Myrbetriq® Extended-Release Tablets), said Zydus https://www.zyduslife.com/zyduslife/ which is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market and is prepared to launch Mirabegron Extended-Release Tablets, 50mg imminently.
Mirabegron https://www.healthindiatpa.com/ 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 in Ahmedabad SEZ, India https://www.makeinindia.com/ .
Speaking on the launch on 22 April 2024, CEO Americas Dr Punit Patel said, “As one of the first suppliers, we are pleased with the launch of generic Mirabegron which will improve access and availability of the generic product https://www.who.int/ for patients in the US market. This is a significant launch for us which will strengthen our growth plans in US market in the current fiscal.”
Mirabegron Extended-Release Tablets USP 25mg and 50mg had annual sales of US$2.42 billion in the US (IQVIA MAT February 2024).
The group now has 393 approvals and has so far filed over 460* ANDAs since the commencement of the filing process in FY 2003-04.
Zydus has a significant presence in cancer related therapies and offers a wide range of solutions with cytotoxic, supportive & targeted drugs. The group employs over 26,000 people worldwide, including 1,400 scientists engaged in R & D, and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. Fiinews.com
