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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: bentracimab
Date Designated: 03/18/2025
Orphan Designation: treatment of patients treated with ticagrelor when reversal of the antiplatelet effects of ticagrelor is needed for major bleeding or nondeferrable surgery/invasive procedure
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
SFJ Pharmaceuticals, Inc.
5000 Hopyard Road, Suite 330
Pleasanton, California 94588
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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