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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Human monoclonal IgG2 antibody against tissue factor pathway inhibitor
Date Designated: 06/25/2019
Orphan Designation: Treatment of Hemophilia B
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 02/10/2020
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Bayer HealthCare LLC
100 Bayer Boulevard
P.O. Box 915
Hanover, New Jersey 07981
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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