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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: C1-esterase inhibitor (recombinant)
Trade Name: RUCONEST
Date Designated: 02/23/1999
Orphan Designation: Treatment of (acute attacks of) angioedema caused by hereditary or acquired C1-esterase inhibitor deficiency.
Orphan Designation Status: Designated/Approved
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.

Marketing approved:

1 Generic Name: C1-esterase inhibitor (recombinant)
Trade Name: RUCONEST
Marketing Approval Date: 07/16/2014
Approved Labeled Indication: Treatment of acute attacks of hereditary angioedema (HAE) in adult and adolescent patients.
Exclusivity End Date: 07/16/2021 
Exclusivity Protected Indication* :  Treatment of acute attacks of hereditary angioedema (HAE) in adult and adolescent patients.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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