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Rasburicase
Product Approval Information - Licensing Action
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 (Text),
(PDF)
Labeling (PDF)
Review 1 -
(PDF Part 1),
(PDF Part 2)
Review 2 -
(PDF)
Review 3 -
(PDF)
Review 4 -
(PDF)
Statistical Review -
(PDF)
Last Updated: 6/24/2003
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Updated: September 25, 2003 |
