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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: human glucagon-like peptide-2 analogue linked to a human immunoglobulin Fc fragment (ready to use pre-filled syringe)
Date Designated: 05/01/2019
Orphan Designation: Treatment of short bowel syndrome
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Hanmi Pharmaceutical Co. Ltd.
14, Wiryeseong-daero
Songpa-gu, Seoul
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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