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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
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* :  
Lundbeck, Inc.
Four Parkway North
Deerfield, Illinois 60015
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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