FDA accepts NDA for Eisai's Banzel

WOODCLIFF LAKE, N.J. Eisai's new drug application for a drug designed as an adjunctive treatment of seizures associated with a rare form of epilepsy has been accepted by the Food and Drug Administration, the drug maker said Monday.

Eisai said its drug, Banzel, is designed to treat seizures associated with Lennox-Gastaut syndrome in children ages 4 years and older and adults. The NDA is for an oral suspension formulation, which was developed to provide a new option for children over four years and adults who have trouble swallowing tablets.

The NDA was submitted to FDA on April 30.

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