Food and Drug Administration
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
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.