Onfi from Lundbeck is FDA approved for Lennox-Gaastaut Syndrome.

The FDA has approved Onfi (clobazam)from Lundbeck (USA) and Sanofi-Aventis (ROW) as adjunctive therapy for seizures associated with Lennox-Gastaut Syndrome (LGS)in patients two years and older. LGS is a rare and severe form of epilepsy that is typically diagnosed in childhood. A Phase III trial in 238 patients with a current or prior diagnosis of LGS showed that high doses of Onfi decreased weekly seizures by an average of 68% compared with a placebo. The drug has been marketed as Frisium in the EU by Sanofi-Aventis for many years.