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# Astellas Pharma Gains Myrbetriq Pediatric Use
- URL: https://www.fdaweb.com/astellas-pharma-gains-myrbetriq-pediatric-use/
- Published: 2021-03-29T12:00:00.000Z
- Updated: 2026-09-14T16:52:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148988

FDA has approved an Astellas Pharma NDA for Myrbetriq (mirabegron extended-release tablets) for treating neurogenic detrusor overactivity (NDO) in pediatric patients aged three years and older who weigh 35 kg or more, and Myrbetriq Granules (mirabegron for extended-release oral suspension) for treating NDO in pediatric patients aged three years and older. The recent approval also led to the agency granting six months of additional pediatric exclusivity for Myrbetriq. The drug was originally approved in 2012 for treating adults with an overactive bladder.

The company says NDO is a type of bladder dysfunction caused by nerve damage and is marked by uncontrolled bladder contractions that can lead to symptoms of urinary frequency, urgency and incontinence. It says about 85% of children with NDO have spina bifida, a congenital spinal cord defect.