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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: a humanized immunoglobulin G (IgG)1kappa monoclonal antibody targeting IL1RAP that has been designed to inhibit signal transduction from IL?1 alpha, IL?1beta, IL?33, IL?36 alpha, IL?36 beta, and IL?36 gamma
Date Designated: 09/05/2023
Orphan Designation: Treatment of Systemic Sclerosis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Otsuka Pharmaceutical Development & Commercialization, Inc.
2440 Research Boulevard
Rockville, Maryland 20850
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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