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news.Lundbeck said that the US Food and Drug Administration's (FDA) is now ready to review its new drug application (NDA) for Clobazam as an adjunctive therapy to treat seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years and older.
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The investigational compound Clobazam, is marketed under the brand names Frisium and Urbanol, is a drug which is a benzodiazepine derivative.
Lundbeck announced Onfi as the proposed US trade name for clobazam.
Lundbeck has submitted the NDA on the basis of the positive results from a Phase III trial which evaluated the safety and efficacy of Onfi as add-on therapy in patients with LGS.
Lundbeck Global Regulatory Affairs vice president Timothy Cunniff said the FDA’s acceptance for review of the Onfi NDA represents a significant milestone for Lundbeck as we work to improve the lives of people living with epilepsy.