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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: donidalorsen
Trade Name: Dawnzera
Date Designated: 09/19/2023
Orphan Designation: Treatment of hereditary angioedema
Orphan Designation Status: Designated/Approved
Ionis Pharmaceuticals
2855 Gazelle Court
Carlsbad, California 92010
United States

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

Marketing approved:

1 Generic Name: donidalorsen
Trade Name: Dawnzera
Marketing Approval Date: 08/21/2025
Approved Labeled Indication: prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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