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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: idebenone
Date Designated: 05/22/2009
Orphan Designation: Treatment of mitochondrial myopathy, encephalopathy, lactic acidosis with stroke-like episodes syndrome (MELAS)
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 07/22/2019
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Santhera Pharmaceuticals (Switzerland) Ltd.
25 Hammerstrasse
Liestal, Basel-Landschaft
Switzerland

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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