Posted by Michael Wonder on 10 Jul 2020
FDA approves expanded Botox (onabotulinumtoxinA) label for the treatment of paediatric patients with spasticity
9 July 2020 - Updated label now includes paediatric patients with lower limb spasticity caused by cerebral palsy.
Allergan today announced that the U.S. FDA approved a supplemental biologics license application that supports expanded use of Botox for the treatment of spasticity in paediatric patients 2 years of age and older, including those with lower limb spasticity caused by cerebral palsy.
This label expansion is based on Allergan and another manufacturer selectively waiving orphan exclusivity marketing rights each company held for the use of their respective neurotoxins in the treatment of paediatric patients with spasticity caused by cerebral palsy. Botox was first approved in June 2019 for the treatment of paediatric patients with upper limb spasticity and in October 2019 for the treatment of paediatric patients with lower limb spasticity, excluding spasticity caused by cerebral palsy.
