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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 15(S)-hydroxy-(5Z,8Z,11Z,13E,17Z)-eicosapentaenoic acid ethyl ester (15(S)-HEPE-EE)
Date Designated: 06/03/2022
Orphan Designation: Treatment of sickle cell disease (SCD)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Afimmune
Trintech Building, South County Business Park
Leopardstown
Dublin 18
Ireland

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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