Skip to Content

Onfi Approval History

  • FDA approved: Yes (First approved October 21st, 2011)
  • Brand name: Onfi
  • Generic name: clobazam
  • Dosage form: Tablets
  • Company: Lundbeck Inc.
  • Treatment for: Lennox-Gastaut Syndrome

Onfi (clobazam) is a benzodiazepine antiepileptic drug for the treatment of patients with Lennox-Gastaut syndrome (LGS).

Development History and FDA Approval Process for Onfi

Oct 24, 2011Approval FDA Approves Onfi for Seizures Associated with Lennox-Gastaut Syndrome
Mar  4, 2011FDA Accepts Lundbeck Inc. Submission of New Drug Application for Clobazam
Jun 11, 2010H. Lundbeck A/S (DK) - Lundbeck will submit an NDA for clobazam for patients with Lennox-Gastaut syndrome with the FDA before year end 2010

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.