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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: 07/10/2019
Orphan Designation: Treatment of small cell lung 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: 03/27/2020
Approved Labeled Indication: IMFINZI is indicated for use, in combination with etoposide and either carboplatin or cisplatin, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
Exclusivity End Date: 03/27/2027 
Exclusivity Protected Indication* :  Indicated in combination with etoposide and either carboplatin or cisplatin, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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