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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 9-cis, 12-cis-11,11-d2-linoleic acid ethyl ester
Date Designated: 05/23/2016
Orphan Designation: Treatment of Friedreich's Ataxia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Retrotope, Inc.
4300 El Camino Real
Suite 201
Los Altos, California 94022
United States

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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