Food and Drug Administration


October 16, 2001

Xigris (Drotrecogin Alfa (Activated)



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