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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 Xa (recombinant), inactivated-zhzo
Trade Name: ANDEXXA
Date Designated: 02/23/2015
Orphan Designation: For reversing the anticoagulant effect of direct or indirect factor Xa inhibitors in patients experiencing a serious uncontrolled bleeding event or who require urgent or emergent surgery
Orphan Designation Status: Designated/Approved
Alexion Pharmaceuticals, Inc.
121 Seaport Boulevard
Boston, Massachusetts 02210
United States

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

Marketing approved:

1 Generic Name: Coagulation factor Xa (recombinant), inactivated-zhzo
Trade Name: ANDEXXA
Marketing Approval Date: 05/03/2018
Approved Labeled Indication: Coagulation factor Xa (recombinant), inactivated-zhzo is indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding
Exclusivity End Date: 05/03/2025 
Exclusivity Protected Indication* :  Coagulation factor Xa (recombinant), inactivated-zhzo is indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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