FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

FDA Expands Botox Label

July 2, 2019
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Allergan has scored another regulatory win for its blockbuster Botox (onabotulinum toxin A), this time winning expanded label approval to treat children for upper limb spasticity.

The approval came after Allergan reported results from two, late-stage clinical trials involving more than 200 pediatric patients, with overwhelming success.

The FDA is still reviewing a separate application, to expand Botox’ label for lower limb spasticity, Allergan says.

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