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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
Date Designated: 09/05/2017
Orphan Designation: Treatment of stage IIb through IV malignant melanoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Reata Pharmaceuticals, Inc.
2801 Gateway Dr.
Suite 150
Irving, Texas 75063
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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