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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Ethyl eicosapentaenoate
Date Designated: 04/06/2000
Orphan Designation: Treatment of Huntington's disease.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Laxdale Ltd.
Kings Park House, Laurelhill Business Park
Polmaise Road
Stirling
United Kingdom

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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