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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: 12/10/2020
Orphan Designation: Treatment of biliary tract cancer
Orphan Designation Status: Designated/Approved
AstraZeneca Pharmaceuticals LP
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: 09/02/2022
Approved Labeled Indication: In combination with gemcitabine and cisplatin, for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC)
Exclusivity End Date: 09/02/2029 
Exclusivity Protected Indication* :  treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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