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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  colchicine
Trade Name:  Colcrys
Date Designated:  09/25/2007
Orphan Designation:  Treatment of familial Mediterranean fever
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  07/29/2009 
Approved Labeled Indication:  Treatment of familial Mediterranean fever
Exclusivity End Date:    07/29/2016 
Exclusivity Protected Indication* :  
AR Holding Company, Inc.
1100 Orthodox Street
Philadelphia, Pennsylvania 19124
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.