The FDA has approved abbreviated new drug applications for several companies including Breckenridge Pharmaceutical, Amneal Pharmaceuticals, and Upsher-Smith to immediately market a generic version of clobazam (Onfi) (Lundbeck) tablets, CIV, 10 mg and 20 mg, and clobazam oral suspension, CIV, 2.5 mg/mL, for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients 2 years of age and older.
Clobazam’s exact mechanism of action is not fully understood, however, it’s thought to involve the potentiation of GABAergic neurotransmission, a result from binding at the benzodiazepine site of the GABAA receptor.