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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Humanized Recombinant Anti-Tumor Necrosis Factor ? Monoclonal Antibody
Date Designated: 11/24/2020
Orphan Designation: Treatment of sarcoidosis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Xentria, Inc.
8700 W. Bryn Mawr, Suite 600S
Chicago, Illinois 60631
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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