Posted by Michael Wonder on 08 Mar 2019
FDA accepts supplemental biologics license applications for Botox (onabotulinumtoxinA) for paediatric patients with upper and lower limb spasticity
7 March 2019 - Applications seek to extend use of Botox for patients 2 to 17 years old.
Allergan today announced that the U.S. FDA has accepted the company's supplemental biologics license applications to expand the Botox (onabotulinumtoxinA) label for the treatment of paediatric patients (2 years of age and older) with upper and lower limb spasticity.
The submissions are based on data from four Phase 3 studies evaluating the safety and efficacy of Botox in more than 600 paediatric patients with upper and lower limb spasticity.
