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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: clobazam
Trade Name: Onfi
Date Designated: 12/18/2007
Orphan Designation: Treatment of Lennox-Gastaut Syndrome
Orphan Designation Status: Designated/Approved
Lundbeck, Inc.
Four Parkway North
Deerfield, Illinois 60015
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: clobazam
Trade Name: Onfi
Marketing Approval Date: 10/21/2011
Approved Labeled Indication: Adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome inpatients 2 years of age or older
Exclusivity End Date: 10/21/2018 
Exclusivity Protected Indication* :  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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