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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
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.

Marketing approved:

1 Generic Name: colchicine
Trade Name: Colcrys
Marketing Approval Date: 07/29/2009
Approved Labeled Indication: Treatment of familial Mediterranean fever
Exclusivity End Date: 07/29/2016 
Exclusivity Protected Indication* :  

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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