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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: durvalumab
Trade Name: Imfinzi
Date Designated: 10/12/2023
Orphan Designation: Treatment of gastric cancer, including gastroesophageal junction cancer
Orphan Designation Status: Designated/Approved
AstraZeneca Pharmaceuticals
1800 Concord Pike
Wilmington, Delaware 19803
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: durvalumab
Trade Name: Imfinzi
Marketing Approval Date: 11/25/2025
Approved Labeled Indication: in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by single-agent Imfinzi, for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC)
Exclusivity End Date: 11/25/2032 
Exclusivity Protected Indication* :  in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by single-agent Imfinzi, for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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