Food and Drug Administration

Oncologic Drugs Advisory Committee

March 4, 2005

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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

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FDA Background Material