Food and Drug Administration

Oncologic Drugs Advisory Committee

September 24, 2002

Briefing Information

NDA 21-399, IRESSA (gefitinib)

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Briefing Document, Dr. Ronald Falcone, PhD, AstraZeneca Pharmaceuticals LP   pdf

Team Leader Comments and Regulatory Background, FDA   doc   htm   pdf

Medical Officer Review, FDA   doc   htm   pdf

Addendum A to Statistics contained in the Medical Officer Review   doc   htm   pdf

Addendum B to statistics contained in the Medical Officer Review   doc   htm   pdf