Iressa FDA Approval History
FDA Approved: Yes (First approved May 5, 2003)
Brand name: Iressa
Generic name: gefitinib
Dosage form: Tablets
Treatment for: Non-Small Cell Lung Cancer
Iressa (gefitinib) is a tyrosine kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have specific epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.
Development Timeline for Iressa
|Jul 13, 2015||ApprovalFDA Approves Iressa (gefitinib) for First-Line Treatment of Metastatic Non-Small Cell Lung Cancer|
|May 5, 2003||ApprovalAstrazeneca Receives FDA Approval for New Cancer Drug Iressa (gefitinib, ZD1839)|
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