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# FDA Approves VESIcare Pediatric Bladder Indication
- URL: https://www.fdaweb.com/fda-approves-vesicare-pediatric-bladder-indication/
- Published: 2020-05-27T12:00:00.000Z
- Updated: 2026-09-14T16:16:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146865

FDA has approved Astellas Pharma’s VESIcare LS (solifenacin succinate) oral suspension to treat neurogenic detrusor overactivity (NDO), a form of bladder dysfunction related to neurological impairment, in children age two and older. VESIcare tablets were approved in 2004 to treat overactive bladder in adults age 18 and older.

An agency [statement](https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-form-bladder-dysfunction-pediatric-patients-young-2-years-age?utm%5Fcampaign=FDA%20Approves%20New%20Treatment%20for%20Bladder%20Dysfunction%20in%20Pediatric%20Patients%20-%20Drug%20Information%20Update&utm%5Fmedium=email&utm%5Fsource=Eloqua) says it is the first FDA-approved treatment for NDO patients as young as age two. It also notes that while the current standard of care for many such patients requires dosing up to three times daily, VESIcare LS is dosed only once a day.

Efficacy for the indication was established in two clinical trials with a total of 95 pediatric NDO patients ages two to 17, FDA [says](https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-form-bladder-dysfunction-pediatric-patients-young-2-years-age?utm%5Fcampaign=FDA%20Approves%20New%20Treatment%20for%20Bladder%20Dysfunction%20in%20Pediatric%20Patients%20-%20Drug%20Information%20Update&utm%5Fmedium=email&utm%5Fsource=Eloqua). The drug’s most common side effects are constipation, dry mouth, and urinary tract infection.