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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: an anti-Claudin 18.2 monoclonal antibody conjugated with MMAE payload
Date Designated: 04/07/2022
Orphan Designation: Treatment of Gastric Cancer, including Gastroesophageal Junction
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
AstraZeneca
16192 Coastal Highway
Lewes, Delaware 19958
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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