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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: recombinant human C1-esterase inhibitor
Date Designated: 02/23/1999
Orphan Designation: prophylactic treatment of angioedema caused by hereditary or acquired C1-esterase inhibitor deficiency.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 01/07/2026
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Pharming Group N.V.
P. O. Box 451 Darwinweg 24
Leiden
Netherlands

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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