Allergan: FDA Approves BOTOX For Pediatric Patients With Upper Limb Spasticity

(RTTNews) - Allergan plc (AGN) announced U.S. FDA approval of the company's sBLA for BOTOX for the treatment of pediatric patients with upper limb spasticity. BOTOX is the First Neurotoxin treatment approved to treat patients of, 2 to 17 years of age, for the therapeutic Indication. The approval was based on data from two Phase 3 studies evaluating BOTOX in over 200 pediatric patients.

The company's additional sBLA for the use of BOTOX to treat pediatric patients with lower limb spasticity, is currently under FDA review, and a decision is expected in the fourth quarter.