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).
Acceptance of the NDA indicates that the FDA has found the company’s submission to be sufficiently complete to review. The NDA was submitted to FDA on April 30, 2010.
The BANZEL oral suspension was developed to provide a new option for children over four years and adults who have trouble swallowing tablets.
About Lennox-Gastaut Syndrome (LGS)
LGS is a rare form of epilepsy that affects 1 to 4 percent of all children with epilepsy. Children and adults living with LGS experience frequent seizures of multiple types that are difficult to control and they can be developmentally delayed.
BANZEL is a triazole derivative that is structurally unrelated to currently marketed AEDs. The clinical significance of this structural difference has not been established. It is believed to exert its effect by regulating the activity of sodium channels in the brain which carry excessive electrical charges that may cause seizures. BANZEL tablets (200 and 400 mg) are FDA approved for the adjunctive treatment of seizures associated with LGS in children four years and older and adults.
BANZEL® Important Safety Information
There are risks associated with the use of BANZEL that you should know about. We encourage you to talk to your healthcare provider about these risks.
Medication Guide: http://www.banzel.com/Docs/Pdf/BANZELmedicationguide.pdf
For Full Prescribing Information, please visit www.banzel.com.
About Eisai Inc.
Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business with fiscal year 2009 (year ended March 31, 2010) sales of approximately $3.9 billion. Eisai’s areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.
Eisai has a global product creation organization that includes U.S.-based R&D facilities in Maryland, Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company’s areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com.
About Eisai Co., Ltd.
Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. Eisai employs approximately 11,000 employees worldwide.
Judee Shuler, 201-746-2241
David Melin, 908-255-6378
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INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Pharmaceutical FDA