Oncologic Drugs Advisory Committee

July 24, 2007

 

BREIFING INFORMATION

----------Important Notice----------

Limited Seating

Seating in Room 1066 of the Advisors and Consultants Conference Room will be limited. Additional seating will be available in Room 1004, where the meeting
may be viewed on live video cast.

No other changes have been made to this meeting.

 

Morning Session

 

Eli Lilly & Co

 

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.

 

Evista (raloxifene Hcl) Eli Lilly & Co

Indication: Invasive Breast Cancer Risk Reduction (pdf)

 

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).

FDA Briefing Material (pdf)

Errata (htm)

 

Afternoon Session

 

GPC Biotech, Inc

 

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.


Orplatna (satraplatin capsules) GPC Biotech, Inc

Indication: Treatment of men with androgen-independent (hormone refractory) prostate cancer that has failed prior chemotherapy (pdf)

 

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).

FDA Briefing Material (pdf)