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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: antibody drug conjugate of metal-binding motif-introduced trastuzumab antibody variant and monomethyl auristatin E
Date Designated: 07/30/2018
Orphan Designation: Treatment of Gastric Cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Alteogen, Inc.
62 Yuseong-daero 1628beon-gil
Yuseong-gu
Daejeon, Daejeon
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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