rufinamide

FDA Drug Profile — Banzel, RUFINAMIDE, rufinamide, Rufinamide

rufinamide is listed in the FDA National Drug Code directory with 11 NDC codes, marketed under brand names including Banzel, RUFINAMIDE, rufinamide. Available dosage forms: tablet, film coated, powder, suspension.

Drug Details

Generic Name
rufinamide
Brand Names
Banzel, RUFINAMIDE, rufinamide, Rufinamide
Application Number
NDA021911
Sponsor
Eisai Inc.
NDC Codes
11
Dosage Forms
TABLET, FILM COATED, POWDER, SUSPENSION
Routes
ORAL
Active Ingredients
RUFINAMIDE

Indications and Usage

1 INDICATIONS AND USAGE Rufinamide oral suspension is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults. Rufinamide oral suspension is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults ( 1 )