1. Gefitinib (Iressa™), NDA 21-399 Medical Review, FDA May 2003.
2. Gefitinib, (Iressa®), NDA 21-399 Pharmacology Review, FDA July 2003.
3. Iressa® (ZD1839, gefitinib) FDA Advisory Committee Meeting Briefing Document NDA 21-399 for the use of IRESSA for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously received platinum-based chemotherapy. August 20, 2002. http://www.fda.gov/ohrms/dockets/ac/02/briefing/3894B1_01_AstraZeneca.pdf.
4. AstraZeneca Global: Gefitinib (Iressa™) marketing authorization application withdrawn in EU. Press Release, January 4, 2005.
5. Iressa™ (gefitinib tablets) Prescribing Information, AstraZeneca April 2004.