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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Coagulation factor IX
Trade Name:  Mononine
Date Designated:  06/27/1989
Orphan Designation:  Replacement treatment and prophylaxis of the hemorrhagic complications of hemophilia B.
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  08/20/1992 
Approved Labeled Indication:  Prevention and control of bleeding in factor IX deficiency, also known as hemophilia B or Christmas disease.
Exclusivity End Date:    08/20/1999 
Exclusivity Protected Indication* :  
Armour Pharmaceutical Company
500 Arcola Road, P.O. Box 1200
Collegeville, Pennsylvania 19426
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.