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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: selective dual small molecule inhibitor of IRAK1 and IRAK4
Date Designated: 01/07/2025
Orphan Designation: treatment of myelodysplastic syndromes
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Rigel Pharmaceuticals, Inc.
611 Gateway Boulevard, Suite 900
South San Francisco, California 94080
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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