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# FDA Approves Dysport for Pediatric Lower Limb Spasticity
- URL: https://www.fdaweb.com/fda-approves-dysport-for-pediatric-lower-limb-spasticity/
- Published: 2016-08-01T12:00:00.000Z
- Updated: 2026-09-14T21:20:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136350

FDA has approved an Ipsen sBLA for Dysport (abobotulinumtoxinA) for injection for treating pediatric lower limb spasticity in children two years of age and older. Approval was based on data from a Phase 3 pivotal study that showed the majority of patients achieved a response lasting 16 to 22 weeks and sometimes longer. The labeling carries a Boxed Warning on the effects of the botulinum toxin that may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism, according to the company.