Food and Drug Administration Anti-Infective Drugs Advisory Committee 10/16/01 slides

Food and Drug Administration

ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE

October 16, 2001

Xigris (Drotrecogin Alfa (Activated)

Slides

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.

Xigris Drotrecogin Alfa (Activated, Holger K. Schilske, MD, PhD, Eli Lilly and Company ppt html

Supplemental Slides, Eli Lilly and Company ppt html

Biologics License Application: Recombinant Human Activated Protein C (rhAPC) [drotrecogin alfa (activated)] Xigris for Severe Sepsis, Linda Forsyth, MD, FDA ppt html

Open Public Hearing

Ed Wiginton, Meningitis Foundation of America, Inc. pdf

Alvin Lever, MA, FCCP, The American College of Chest physicians, and the CHEST Foundation pdf htm doc