Food and Drug Administration
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.
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
Disclaimer
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.