FDA Oncologic Drugs Advisory Committee 1/31/02 Briefing Information

Food and Drug Administration

Oncologic Drugs Advisory Committee

January 31, 2002

sNDA21-386, Zometa® (zoledronic acid for injection)

Briefing Information

Sponsor Briefing Information

Novartis Pharmaceuticals Corporation

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 Package pdf htm doc

Appendix 3 pdf htm doc

Food and Drug Administration

Part 1 Clinical Briefing pdf doc

Part 2 Appendix 1-Review of Zoledronate Safety in Prostate Cancer, Sutdy 039 pdf htm doc

Part 3 Statistical Review pdf htm doc