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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: gefitinib
Trade Name: Iressa
Date Designated: 08/26/2014
Orphan Designation: Treatment of epidermal growth factor receptor mutation-positive non-small cell lung cancer
Orphan Designation Status: Designated/Approved
AstraZeneca Pharmaceuticals LP
1800 Concord Pike
P. O. Box 8355
Wilmington, Delaware 19803
United States

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

Marketing approved:

1 Generic Name: gefitinib
Trade Name: Iressa
Marketing Approval Date: 07/13/2015
Approved Labeled Indication: For the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test
Exclusivity End Date: 07/13/2022 
Exclusivity Protected Indication* :  For the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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