Food and Drug Administration

Oncologic Drugs Advisory Committee

March 3, 2005

Briefing Information

Advanced Magnetics, Incorporated

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 New Drug Application (NDA) 21-115 Combidex (ferumoxtrax-10) Advanced Magnetics, Incorporated, proposed indication for intravenous administration as a Magnetic Resonance Imaging (MRI) contrast agent to assist in the differentiation of metastatic and non-metastatic lymph nodes in patients with confirmed primary cancer who are at risk for lymph node metastases.


Combidex (ferumoxtrax-10) Briefing Material
Appendix A
Appendix B
Appendix C
Appendix D
Appendix E
Appendix F
Appendix G
Appendix H

FDA

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.

FDA Backgrounder

FDA

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.


The committee will discuss prostate cancer endpoints as a follow up to the June 2004 FDA Workshop.


 

FDA Backgrounder