mirabegron
Drug Details
- Generic Name
- mirabegron
- Brand Names
- MIRABEGRON, Myrbetriq, Mirabgeorn, Mirabegron
- Application Number
- ANDA209485
- Sponsor
- Lupin Pharmaceuticals, Inc.
- NDC Codes
- 16
- Dosage Forms
- TABLET, FILM COATED, EXTENDED RELEASE, POWDER, GRANULE, FOR SUSPENSION, EXTENDED RELEASE
- Routes
- ORAL
- Active Ingredients
- MIRABEGRON
Indications and Usage
1 INDICATIONS AND USAGE Mirabegron extended-release tablets are beta-3 adrenergic agonists indicated for the treatment of: • Overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. ( 1.1 ) • Neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more. ( 1.2 ) 1.1 Adult Overactive Bladder (OAB) Mirabegron Extended-Release Tablets Monotherapy Mirabegron extended-release tablets are indicated for the treatment of OAB in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. 1.2 Pediatric Neurogenic Detrusor Overactivity (NDO) Mirabegron extended-release tablets are indicated for the treatment of NDO in pediatric patients aged 3 years and older and weighing 35 kg or more.