Posted by Michael Wonder on 28 May 2017
U.S. FDA accepts for review supplemental new drug application for Aptiom (eslicarbazepine acetate) for the treatment of partial-onset seizures in children 4 to 17 years of age
22 May 2017 - If approved, Aptiom would provide an important monotherapy or adjunctive therapy treatment option for pediatric patients who experience partial-onset seizures.
Sunovion Pharmaceuticals today announced that the U.S. FDA has accepted for review the supplemental new drug application to expand the indication for its antiepileptic drug Aptiom (eslicarbazepine acetate) to include use as monotherapy or adjunctive therapy for the treatment of partial-onset seizures in children four to 17 years of age.
The expected action date by the FDA under the Prescription Drug User Fee Act is 13 September 2017.
