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Onfi Approval History

FDA Approved: Yes (First approved October 21, 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

DateArticle
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

Further information

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