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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: bi-specific fragment crystallizable region (Fc) fusion protein containing cluster of differentiation 80 ectodomain as an N-terminal moiety and interleukin-2 variant as a C-terminal moiety conjugated with human immunoglobulin G4 Fc
Date Designated: 10/17/2022
Orphan Designation: Treatment of Merkel cell carcinoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
GI Innovation, Inc.
A-1116 Tera Tower, 167, Songpa-daero
Songpa-gu, Seoul 05855
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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