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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)-(3-bromo-4-(trifluoromethyl)phenyl)(2-(5-methyl-[1,2,4]triazolo[1,5-a]pyrimidin-7-yl)morpholino)methan-one
Date Designated: 03/30/2026
Orphan Designation: treatment of catecholaminergic polymorphic ventricular tachycardia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Agiana Pharmaceuticals
Gaustadalléen 21
Oslo
Norway

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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