Posted by Michael Wonder on 27 May 2020
FDA approves first treatment for a form of bladder dysfunction in paediatric patients as young as 2 years of age
26 May 2020 - The U.S. FDA today granted approval to VESIcare LS (solifenacin succinate) oral suspension for the treatment of neurogenic detrusor overactivity, a form of bladder dysfunction related to neurological impairment, in children ages two years and older.
VESIcare (solifenacin succinate) tablets were initially approved in 2004 for the treatment of overactive bladder in adults 18 years and older.
The efficacy of VESIcare LS for this use was established in two clinical trials with a total of 95 paediatric neurogenic detrusor activity patients, ages two to 17 years old.
