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Allergan: FDA Approves BOTOX For Pediatric Patients - Quick Facts

Allergan plc (AGN) said the U.S. FDA has approved the company's supplemental Biologics License Application, or sBLA, for BOTOX for the treatment of pediatric patients with lower limb spasticity, excluding spasticity caused by cerebral palsy. The company noted that the approval marks 11th BOTOX therapeutic indication.

The FDA approval is based on a phase 3 study evaluating the safety and efficacy of BOTOX in more than 300 pediatric patients aged two to 17 years old being treated for lower limb spasticity.

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