Drotrecogin alfa 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

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Approval Letter (PDF - 50KB)

Label (PDF - 241KB)

Clinical Review Part 1 (PDF - 984KB)

Clinical Review Part 2 (PDF - 468KB)

Toxicology Review (PDF - 10KB)

Immunogenicity Review (PDF - 340KB)

Drug Substance Review (PDF - 104KB)

CMC Review 1 (PDF - 46KB)

CMC Review 2 (PDF - 209KB)

CMC Review 3 (PDF - 55KB)