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news.FDA has accepted to review Eisai's new drug application (NDA) for a new oral suspension (40mg/ml) formulation of an antiepileptic agent Banzel (generic name: rufinamide).
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Eisai said that the oral suspension formulation was developed to provide a new treatment option for children four years and older and adults who have trouble swallowing tablets.
Eisai added that the proposed indication is for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children four years and older and adults.
Eisai had submitted the NDA to the FDA on April 30, 2010, based on data from a study designed to demonstrate the bioequivalence of the oral suspension formulation to the currently marketed Banzel tablet formulation (400mg).
Banzel tablets (200 mg and 400 mg) were approved in the US by the FDA in November 2008 and are currently prescribed for the adjunctive treatment of seizures associated with LGS in children four years and older and adults.