Food and Drug Administration

Oncologic Drugs Advisory Committee Meeting

September 13, 2005

AM Session

Abbot Laboratory Briefing Material

The statements contained in this document(s) are not those of the FDA, and FDA does not necessarily agree with these statements.
FDA has not made a final determination about the issues to be discussed at the Advisory Committee meeting.

Xinlay™ (atrasentan hydrochloride) capsules briefing material

 

Food and Drug Administration

Disclaimer

Portions of these documents may 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 Xinlay™ Clinical Review

FDA Xinlay™ Statistical Review

FDA Xinlay™ Errata Sheet

 

September 13, 2005

PM Session

OSI Pharmaceuticals Inc.

The statements contained in this document(s) are not those of the FDA, and FDA does not necessarily agree with these statements.
FDA has not made a final determination about the issues to be discussed at the Advisory Committee meeting.

Tarceva™ (erlotinib) tablets briefing material

 

Food and Drug Administration

Disclaimer

Portions of these documents may 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 Tarceva™ Clinical Review

FDA Tarceva™ Statistical Review

FDA Tarceva™ Errata Sheet