BioCentury
ARTICLE | Clinical News

FDA accepts Sunovion's Aptiom sNDA for pediatric seizures

May 26, 2017 7:49 PM UTC

The Sunovion Pharmaceuticals Inc. unit of Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506) said FDA accepted for review an sNDA for Aptiom eslicarbazepine acetate (Zebinix - EU) (BIA 2-093, SEP-0002093) as monotherapy or adjunctive therapy to treat partial-onset seizures in children ages ≥4. The voltage-gated sodium channel blocker is approved for the indications in adults...