Botox® (onabotulinumtoxinA) receives US FDA approval for paediatric Detrusor Overactivity associated with a neurologic condition

Approval is based Phase 3 study in more than 100 paediatric patients which met the study’s primary endpoint; demonstrating intradetrusor administration of Botox 200 Units (not to exceed 6U/kg) reduced daytime urinary incontinence episodes.

Source:

Biospace Inc.