Eisai Resubmits NDA Application for the Anti-epilepsy Drug Rufinamide

Main Category: Epilepsy
Article Date: 19 Nov 2005 - 16:00 PDT

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Eisai Medical Research Inc., a U.S. pharmaceutical subsidiary of Eisai Co., Ltd., announced that they resubmitted the New Drug Application (NDA) for the anti-epilepsy agent rufinamide on Nov. 16, 2005. Eisai Medical Research had withdrawn the original NDA in early November and has supplemented its filing to include copies of some of the data from the original NDA in a more accessible electronic format.

Rufinamide has been evaluated as an adjunctive treatment for partial-onset seizures in adult and adolescent patients (12 years and older) and as adjunctive treatment for seizures associated with Lennox-Gastaut Syndrome (LGS) in children (4 years and older).

About Eisai Co., Ltd.

Eisai Co., Ltd. is a research-based human health care company that discovers, develops and markets products in more than 30 countries. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai employs 8,000 people worldwide.

About Eisai Medical Research Inc.

Eisai Medical Research Inc. is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd. Eisai Medical Research Inc. was established to focus solely on clinical research and to expedite clinical drug development of new chemical entities and of new indications for marketed products.

www.eisai.com

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