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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: garadacimab-gxii
Trade Name: Andembry
Date Designated: 04/30/2020
Orphan Designation: Treatment of bradykinin-mediated angioedema
Orphan Designation Status: Designated/Approved
CSL Behring
1020 First Avenue
PO Box 61501
King of Prussia, Pennsylvania 19406
United States

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

Marketing approved:

1 Generic Name: garadacimab-gxii
Trade Name: Andembry
Marketing Approval Date: 06/16/2025
Approved Labeled Indication: prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older
Exclusivity End Date: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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