Long-term Extension Study of BOTOX in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 5 to 17 Years of Age
Latest Information Update: 22 Oct 2021
At a glance
- Drugs Botulinum-Toxin-A (Primary)
- Indications Urinary incontinence
- Focus Registrational; Therapeutic Use
- Sponsors Allergan
- 10 Feb 2021 According to an AbbVie media release, the U.S. 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 who have an inadequate response to or are intolerant of anticholinergic medication. The FDA approval is based on data from a randomized, double-blind Phase 3 study and a long-term extension study.
- 10 Feb 2021 Results presented in an AbbVie media release.
- 20 Dec 2019 Status changed from active, no longer recruiting to completed.