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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: (S)-N-(2-methoxy-5-((5-(trifluoromethyl)pyridin-2-yl)oxy)phenyl)-3- methy1-2-oxoimidazolidine-4-carboxamide
Date Designated: 04/18/2026
Orphan Designation: treatment of mesothelioma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Orion Corporation
1 Broadway
14th Floor
Cambridge, Massachusetts 02142
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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