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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: N-((4-([1,2,4]triazolo[1,5-a]pyridin-6-yl)-5-(6-methylpyridin-2-yl)-1H-imidazol-2-yl)methyl)-2-fluoroaniline
Date Designated: 06/14/2017
Orphan Designation: Treatment of hepatocellular carcinoma
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 06/29/2023
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
MedPacto, Inc.
145 Gwanggyo-ro
Advanced Institutes of Convergence Technology
Suwon, Gyeonggi-do
South Korea

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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