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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: recombinant humanized IgG1 anti-TROP2 monoclonal antibody conjugated to a topoisomerase I inhibitor
Date Designated: 06/18/2024
Orphan Designation: treatment of gastric cancer including cancer of the gastroesophageal junction
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Merck, Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (MSD)
126 East Lincoln Avenue
Rahway, New Jersey 07065
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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