Search Orphan Drug Designations and Approvals
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Generic Name: | human monoclonal IgG2 antibody against tissue factor pathway inhibitor (TFPI) |
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Date Designated: | 03/25/2019 |
Orphan Designation: | Treatment of Hemophilia A |
Orphan Designation Status: | Designated/Designation Withdrawn or Revoked |
Date Designation Withdrawn or Revoked: | 02/10/2020 |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 |
Sponsor: |
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. |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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