Eisai Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) submitted by its U.S. subsidiary Eisai Inc. for Eisai's antiepileptic agent Banzel (generic name: rufinamide), which was approved in November 2008 for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children four years older and adults. This application seeks an additional indication for pediatric patients from one to three years of age.

The sNDA was submitted to the FDA by Eisai Inc. on August 12, 2014. Acceptance of the sNDA indicates that the FDA has found the company's submission to be sufficiently complete to review. Furthermore, Priority Review designation was assigned to this sNDA because the FDA requested this pediatric data under the Best Pharmaceuticals for Children Act. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date (proposed review deadline) of February 12, 2015.

For more details, go to: http://www.eisai.com/news/news201461.html