Myrbetriq Approval History beta

  • FDA approved: Yes (First approved June 28th, 2012)
  • Brand name: Myrbetriq
  • Generic name: mirabegron
  • Company: Astellas Pharma Inc.
  • Treatment for: Overactive Bladder

Myrbetriq (mirabegron) is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

FDA Approval History for Myrbetriq

DateArticle
Jun 28, 2012Approval FDA Approves Myrbetriq for Overactive Bladder
Apr  5, 2012FDA Advisory Committee Recommends Approval of Mirabegron - Investigational Overactive Bladder Treatment from Astellas
Nov 11, 2011Receipt of Filing Communication Letter from U.S. FDA Regarding Mirabegron (YM178)
Aug 29, 2011Astellas Pharma Inc.: Announcement of Regulatory Submission for Mirabegron (YM178), a Treatment for Overactive Bladder, in U.S. and Europe

See also...

Myrbetriq (mirabegron) Consumer Information

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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