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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Glucagon-like peptide-1/Glucagon/Gastric inhibitory polypeptide triple agonist linked to human IgG4 Fc fragment
Date Designated: 03/09/2020
Orphan Designation: Treatment of primary biliary cholangitis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Hanmi Pharmaceutical Company, Ltd.
14, Wiryeseong-daero
Seoul, Songpa-gu
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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