The FDA approved Onfi for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years and older.
Onfi is an oral anti-epileptic drug (AED) of the benzodiazepine class, and is a 1,5 benzodiazepine.
Onfi is a federally controlled schedule four substance (C-IV), the company said.
Lundbeck commercial operations executive vice president Marie-Laure Pochon said that Onfi has in clinical studies shown to be an effective add-on therapy for seizures associated with LGS.