FDA Approves Seizure Treatment For Patients With Lennox-Gastaut Syndrome

The Food and Drug Administration Oct. 24 announced that it has approved Onfi tablets (clobazam) for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome in adults and children two years of age and older.

As Onfi is intended to treat a disease or condition that affects fewer than 200,000 people in the United States, it was granted orphan drug designation, the agency said. The drug is manufactured by Winchester, Ky.-based Catalent Pharma Solutions LLC for Deerfield, Ill.-based Lundbeck Inc.

“Lennox-Gastaut syndrome is a severe form of epilepsy that causes debilitating seizures,” Russell Katz, director of the ...