Posted by Michael Wonder on 17 Sep 2017
Sunovion’s Aptiom (eslicarbazepine acetate) receives FDA approval for expanded indication to treat partial-onset seizures in children and adolescents 4 years of age and older
14 September 2017 - Aptiom provides an important new treatment option for children and adolescents four to 17 years of age with partial-onset seizures.
Sunovion Pharmaceuticals today announced that the U.S. FDA approved the supplemental new drug application to expand the indication for its anti-epileptic drug Aptiom (eslicarbazepine acetate) to include treatment of partial-onset seizures in children and adolescents four to 17 years of age.
The approval to expand Aptiom’s indication to include children four years of age and older is based on FDA guidance that permits the extrapolation of data to support paediatric use.
