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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: humanized anti-Globo H monoclonal antibody
Date Designated: 11/20/2018
Orphan Designation: Treatment of pancreatic cancer
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 08/21/2024
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
OBI Pharma USA, Inc.
6020 Cornerstone Court W, Suite 200
San Diego, California 92121
United States

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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