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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 (recombinant), Fc fusion protein
Trade Name: ALPROLIX
Date Designated: 10/30/2008
Orphan Designation: Control and prevention of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency or Christmas disease)
Orphan Designation Status: Designated/Approved
Bioverativ Therapeutics, Inc.
225 2nd Avenue
Waltham, Massachusetts 02451
United States

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

Marketing approved:

1 Generic Name: Coagulation factor IX (recombinant), Fc fusion protein
Trade Name: ALPROLIX
Marketing Approval Date: 03/28/2014
Approved Labeled Indication: Adults and children with Hemophilia B for control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
Exclusivity End Date: 03/28/2021 
Exclusivity Protected Indication* :  Adults and children with Hemophilia B for control and prevention of bleeding episodes, perioperative management, and 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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