Food and Drug Administration

Oncologic Drugs Advisory Committee

March 4, 2005


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.

The committee will discuss (1) the results of a confirmatory trial for NDA 21-399, Iressa (gefitinib) AstraZeneca

Pharmaceuticals LP and , and (2) Safety concerns, specifically osteonecrosis of the jaw (ONJ), associated with two bisphosponates, NDA 21-223, Zometa (zoledronic acid) Injection and Aredia (pamidronate disodium for injection), both Novartis Pharmaceuticals Corporation.


Astra Zeneca L.P Briefing Material
Appendix A
Appendix B


Novartis Pharmaceutical Briefing Material
[Word] [PDF] [HTML]

Appendix 1 [Word] [PDF] [HTML]
Appendix 2 [Word] [PDF] [HTML]
Appendix 3 [Word] [PDF] [HTML]
Appendix 4 [Word] [PDF] [HTML]
Appendix 5 [Word] [PDF] [HTML]
Appendix 6 [Word] [PDF] [HTML]
Appendix 7 [Word] [PDF] [HTML]
Appendix 8 [Word] [PDF] [HTML]
Appendix 9 [PDF]
Appendix 10 [Word] [PDF] [HTML]
Appendix 11 [Word] [PDF] [HTML]

FDA Briefing Material


Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. 552). These redacted portions will appear as white space on the screen or on the printed page.

FDA Background Material