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Iressa FDA Approval History

FDA Approved: Yes (First approved May 5, 2003)
Brand name: Iressa
Generic name: gefitinib
Dosage form: Tablets
Company: AstraZeneca
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, 2015Approval FDA Approves Iressa (gefitinib) for First-Line Treatment of Metastatic Non-Small Cell Lung Cancer
May  5, 2003Approval Astrazeneca Receives FDA Approval for New Cancer Drug Iressa (gefitinib, ZD1839)

Further information

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