Rasburicase Product Approval Information - Licensing Action 7/12/02

Proper name: Rasburicase
Tradename: Elitek
Manufacturer: Sanofi-Synthelabo, Inc, Malvern, PA, License #1294
Indication for Use: Initial management of plasma uric acid levels in pediatric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid
Approval Date: 7/12/2002
Type of Submission: Biologics license application

Approval Letter (PDF)

Labeling (PDF)

Review 1 - Part 2 (PDFs)

Review 2 - (PDF)

Review 3 - (PDF)

Review 4 - (PDF)

Statistical Review - (PDF)