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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: danicopan
Trade Name: Voydeya
Date Designated: 11/02/2017
Orphan Designation: Treatment of paroxysmal nocturnal hemoglobinuria
Orphan Designation Status: Designated/Approved
Alexion Pharmaceuticals, Inc
300 George Street
New Haven, Connecticut 06511
United States

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

Marketing approved:

1 Generic Name: danicopan
Trade Name: Voydeya
Marketing Approval Date: 03/29/2024
Approved Labeled Indication: add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH)
Exclusivity End Date: 03/29/2031 
Exclusivity Protected Indication* :  treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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