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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
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
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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