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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: brepocitinib
Date Designated: 05/25/2025
Orphan Designation: treatment of dermatomyositis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Priovant Therapeutics, Inc.
1007 Slater Rd
Suite 250
Durham, North Carolina 27703
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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