Posted by Michael Wonder on 22 Jun 2020
FDA accepts supplemental biologics license application for Botox (onabotulinumtoxinA) for the treatment of paediatric patients with neurogenic detrusor overactivity
22 June 2020 - Application seeks to extend use of Botox for patients 5 to 17 years old.
Allergan today announced that the U.S. FDA has accepted the company's supplemental biologics license application to expand the Botox prescribing information for the treatment of signs and symptoms of detrusor (bladder muscle) overactivity associated with an underlying neurologic condition (e.g., spina bifida, spinal cord injuries) in paediatric patients (5 -17 years of age) who have an inadequate response to, or are intolerant of, or for any reason unwilling to continue anticholinergic medication.
