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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: nemolizumab
Date Designated: 01/13/2026
Orphan Designation: treatment of systemic sclerosis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Galderma Research and Development, LLC
2001 Ross Avenue, Suite 1600
Dallas, Texas 75201
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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