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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: A (recombinant) disintegrin and metalloprotease with thrombospondin type 1 repeats, member 13 (ADAMTS13) protein
Date Designated: 09/27/2023
Orphan Designation: Treatment of Thrombotic Thrombocytopenic Purpura
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
GC Biopharma Corp.
107, Ihyeon-ro 30beon-gil, Giheung-gu
Yongin-si, Gyeonggi-do 16924
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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