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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 225Ac chelated with SKL35500 (consists of a ligand, a neurotensin receptor 1 (NTSR1) targeting compound, a chelator, dodecane tetraacetic acid (DOTA), and linker, aminopropyl methyl aminopropanol)
Date Designated: 10/05/2026
Orphan Designation: treatment of pancreatic cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
SK Life Science, Inc.
461 From Road, 5th Floor
Paramus, New Jersey 07652
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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