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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Caplacizumab
Trade Name: CABLIVI
Date Designated: 04/14/2009
Orphan Designation: Treatment of thrombotic thrombocytopenic purpura
Orphan Designation Status: Designated/Approved
Ablynx, a wholly owned subsidiary of Sanofi Group
55 Corporate Drive
Bridgewater, New Jersey 08807
United States

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

Marketing approved:

1 Generic Name: Caplacizumab
Trade Name: CABLIVI
Marketing Approval Date: 02/06/2019
Approved Labeled Indication: CABLIVI is indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.
Exclusivity End Date: 02/06/2026 
Exclusivity Protected Indication* :  CABLIVI is indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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