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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP)
Trade Name: Idelvion
Date Designated: 04/27/2012
Orphan Designation: Treatment of patients with congenital factor IX deficiency (hemophilia B).
Orphan Designation Status: Designated/Approved
CSL Behring, LLC
1020 First Avenue
P.O. Box 61501
King of Prussia, Pennsylvania 19406
United States

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

Marketing approved:

1 Generic Name: recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP)
Trade Name: Idelvion
Marketing Approval Date: 03/04/2016
Approved Labeled Indication: Indicated in children and adults with hemophilia B (congenital Factor IX deficiency) for the (1) on-demand control and prevention of bleeding episodes, (2) perioperative management of bleeding, and (3) routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
Exclusivity End Date: 03/04/2023 
Exclusivity Protected Indication* :  Indicated for the (1) on-demand control and prevention of bleeding episodes, (2) perioperative management of bleeding, and (3) routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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