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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: rasburicase
Trade Name: Elitek
Date Designated: 10/11/2000
Orphan Designation: Treatment of malignancy-associated or chemotherapy-induced hyperuricemia.
Orphan Designation Status: Designated/Approved
Sanofi-Synthelabo Research
9 Great Valley Parkway
Malvern, Pennsylvania 19355
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: rasburicase
Trade Name: Elitek
Marketing Approval Date: 07/12/2002
Approved Labeled Indication: 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.
Exclusivity End Date: 07/12/2009 
Exclusivity Protected Indication* :  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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