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Zydus Lifesciences launches Mirabegron ER Tablets in US for overactive bladder treatment

Ruchika SharmaWritten by Ruchika Sharma Published On 2024-04-22T14:47:55+05:30  |  Updated On 22 April 2024 2:47 PM IST
  • Zydus Lifesciences launches Mirabegron ER Tablets in US for overactive bladder treatment
  • Zydus Lifesciences launches Mirabegron ER Tablets in US for overactive bladder treatment
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Mirabegron is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency.

Ahmedabad: Zydus Lifesciences Limited has announced the launch of Mirabegron Extended-Release Tablets, 25 mg in the US market.

The company had earlier received final approval from the United States Food and Drug Administration (USFDA) to market Mirabegron Extended-Release Tablets USP 25 mg and 50 mg (USRLD: Myrbetriq Extended-Release Tablets).

Zydus 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 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.

Speaking on the launch, 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 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 USD 2.42bn 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.

Read also: Zydus Lifesciences arm gets marketing nod for Nulibry from UK MHRA for MoCD Type A

Headquartered in Ahmedabad, Zydus Lifesciences Limited is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group 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.

Read also: Zydus Lifesciences receives tentative approval from USFDA for Letermovir Tablets

zydus lifescienceszydus lifesciences newsMirabegron Extended Release TabletsUSFDAMyrbetriq Extended Release Tabletsoveractive bladder
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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