WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Eisai Inc. (Headquarters: Woodcliff Lake, NJ; President and CEO: Lonnel Coats), a U.S. subsidiary of Eisai Co., Ltd. (Headquarters: Tokyo; President and CEO: Haruo Naito) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Eisai’s NDA for BANZEL® (rufinamide) Oral Suspension (40 mg/mL). The proposed indication is for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children four years and older and adults. The application is based on data from a study designed to demonstrate the bioequivalence of the oral suspension formulation to the currently marketed BANZEL tablet formulation (400 mg).
