RIDGEFIELD PARK, N.J.- Eisai Medical Research Inc. (Headquarters:
Ridgefield Park, NJ, President: Mindell Seidlin), a U.S.
pharmaceutical subsidiary of Eisai Co., Ltd. , announced today 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Eisai Medical Research had withdrawn the original NDA in early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.
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