Myrbetriq

NDA 202611, held by Apgdi. Mirabegron.

As of Nov 14, 2026, NDA 202611 (Myrbetriq), held by Apgdi, was first approved by FDA on Jun 28, 2012, with 11 approved supplements and 0 published complete response letters.

First approved: Jun 28, 2012
Review: Standard
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

MYRBETRIQ is a beta-3 adrenergic agonist indicated for the treatment of:

Overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency, either alone or in combination with the muscarinic antagonist solifenacin succinate.
Neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more. MYRBETRIQ Granules is a beta-3 adrenergic agonist indicated for the treatment of NDO in pediatric patients aged 3 years and older. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below


Mar 25, 2021	Supplement 17Efficacy (new indication or use) · Priority review	Approved	Letter Label
Apr 27, 2018	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 28, 2012	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Myrbetriq25MG · tablet, extended release;oral	Mirabegron	RxReference drug
Myrbetriq50MG · tablet, extended release;oral	Mirabegron	RxReference drug

All 12 submissions, including labeling and manufacturing supplements


Mar 25, 2021	Supplement 17Efficacy (new indication or use) · Priority review	Approved	Letter Label
Apr 27, 2018	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 28, 2017	Supplement 12Labeling · Standard review	Approved	Letter Label
Aug 16, 2016	Supplement 7Labeling · Standard review	Approved	Label Letter
Aug 1, 2016	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 2, 2015	Supplement 5Labeling · Standard review	Approved	Label Letter
Aug 10, 2015	Supplement 6Labeling · Standard review	Approved	Letter Label
Feb 9, 2015	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 13, 2014	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 19, 2013	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 4, 2013	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 28, 2012	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 202611
Drugs@FDA: Overview at FDA
Company: APGDI

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters