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Myrbetriq FDA Approval History

Last updated by Judith Stewart, BPharm on March 29, 2021.

FDA Approved: Yes (First approved June 28, 2012)
Brand name: Myrbetriq
Generic name: mirabegron
Dosage form: Extended Release Tablets and Granules
Company: Astellas Pharma Inc.
Treatment for: Overactive Bladder; Neurogenic Detrusor Overactivity

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, and neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more.
Myrbetriq Granules is indicated for the treatment of NDO in pediatric patients aged 3 years and older.

Development timeline for Myrbetriq

Mar 26, 2021Approval FDA Approves New Indication & New Product Formulation for Myrbetriq for Use in Children with Neurogenic Detrusor Overactivity (NDO)
May  7, 2018Approval FDA Approves Supplemental New Drug Application for Myrbetriq (mirabegron) for Use in Combination with Solifenacin Succinate for the Treatment of Overactive Bladder Symptoms
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

Further information

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