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
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