Banzel
Generic name: rufinamide
Treatment for: Lennox-Gastaut Syndrome
Eisai Resubmits NDA for the Anti-epilepsy Drug Rufinamide
RIDGEFIELD PARK, N.J., November 18, 2005 -- 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 Eisai Medical Research had withdrawn the original NDA in early November and has supplemented its filing to include copies of some of the data from the original NDA in a more accessible electronic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).
Source: Eisai Co., Ltd.
Posted: November 2005
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Banzel (rufinamide) FDA Approval History
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