June 22, 2020
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FDA accepts application for expanded use of Botox in children

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The FDA accepted a supplemental biologics license application to expand the use of Botox for the treatment of signs and symptoms of neurogenic detrusor overactivity in children, Allergan announced.

The application is for the expanded use of Botox in children aged 5 to 17 years with bladder muscle overactivity associated with conditions such as spina bifida or spinal cord injuries “who have an inadequate response to, or are intolerant of, or for any reason unwilling to continue anticholinergic medication,” Allergan said in a news release.

The application was based on data from a phase 3 randomized, double-blind study conducted among more than 100 pediatric patients with neurogenic detrusor overactivity and a long-term extension study.

Allergan expects a decision in the first quarter of 2021 after a standard 10-month review.