WASHINGTON (dpa-AFX) - Allergan, an AbbVie (ABBV) company, announced the FDA has approved BOTOX for the treatment of detrusor (bladder muscle) overactivity associated with a neurologic condition in pediatric patients 5 years of age and older. The FDA approval was based on data from a double-blind Phase 3 study evaluating the safety and efficacy of BOTOX in more than 100 pediatric patients with neurogenic detrusor overactivity and a long-term extension study.
Allergan noted that this milestone marks the 12th approved therapeutic indication for BOTOX.
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