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Drotrecogin alfa (activated)
Product Approval Information - Licensing Action
Proper name: Drotrecogin alfa (activated)
Tradename: Xigris
Manufacturer: Eli Lilly and Co, Indianapolis, IN , License #1611
Indication for Use: Reduction of mortality in adult patients with severe sepsis (sepsis associated with acute organ dysfunction) who have a high risk of death (e.g., as determined by APACHE II)
Approval Date: 11/21/2001
Type of submission: Biologics license application
Approval Letter -
(Text),
(PDF)
Label -
(PDF)
Clinical Review -
Part 1 (PDF),
Part 2 (PDF),
(Text)
Toxicology Review -
(PDF),
(Text)
Immunogenicity Review -
(PDF),
(Text)
Drug Substance Review -
(PDF)
CMC Review 1 -
(PDF)
CMC Review 2 -
(PDF)
CMC Review 3 -
(PDF)
FDA News Release
Last Updated: 6/20/2003
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Updated: September 25, 2003 |
