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Myrbetriq Approval History

  • FDA approved: Yes (First approved June 28th, 2012)
  • Brand name: Myrbetriq
  • Generic name: mirabegron
  • Dosage form: Extended Release Tablets
  • 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.

Development History and FDA Approval Process for Myrbetriq

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

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