The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is
'These regulatory submissions mark an important step toward addressing the unmet treatment needs for children with neurogenic detrusor overactivity. Treatment options for children with neurogenic detrusor overactivity are limited,' said
NDO is a neurological bladder dysfunction caused by nerve damage. Children with NDO may experience involuntary bladder contractions, which can lead to symptoms of urinary urgency, frequency and incontinence.1 Spina bifida, a congenital spinal cord defect, is a common cause of NDO in children.2
The NDA and sNDA were based on findings from a Phase 3 pivotal study that evaluated the efficacy, safety, tolerability and pharmacokinetics of mirabegron in children and adolescents (aged 3 to
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