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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: omaveloxolone
Trade Name: Skyclarys
Date Designated: 06/19/2017
Orphan Designation: Treatment of Friedreich's Ataxia
Orphan Designation Status: Designated/Approved
Biogen U.S. Corporation
225 Binney Street
Cambridge, Massachusetts 02142
United States

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

Marketing approved:

1 Generic Name: omaveloxolone
Trade Name: Skyclarys
Marketing Approval Date: 02/28/2023
Approved Labeled Indication: treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older
Exclusivity End Date: 02/28/2030 
Exclusivity Protected Indication* :  treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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