RASBUR Protocol / Clinical Study Jude News Donate Now Contact Us Shop En Espanol Patients & Parents Clinical Science Basic Science Referring MDs Careers International Volunteers Ways to Help Supportive Leukemia / Lymphoma Studies - Home - Clinical Science Home - Protocols - Leukemias / Lymphomas - Supportive Leukemia / Lymphoma Studies - Related Topics Sima Jeha, MD - Protocol RASBUR Protocol / Clinical Study...
author: St. Jude Children's Research Hospital
Therapeutic Biological Approvals FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Therapeutic Biological Approvals - Tradename/ Proper Name Indication for Use STN Manufacturer/ License NoElitek Rasburicase Initial management of plasma uric acid levels in pediatric patients with leukemia,...
Rasburicase - Product Approval Information - Licensing Action FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -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,...
Rasburicase Letter - Product Approval Information - Licensing Action - To conduct a study designed to assess the comparative safety and efficacy of the approved dose and schedule of Rasburicase with a regimen of sequential Rasburicase and allopurinol
Prescription Drug User Fee Act - User Fee Billable Therapeutic Products: Approved Under Section 351 of the PHS Act u/vial MedImmune, Inc License 1252 Synagis Palivizumab 103770/0 6/19/1998 50 mg/vial 100 mg/vial Merck & Co., Inc License 0002 Elspar Asparaginase 101063/0 1/10/1978 10,000 IU/vial Novartis Pharmaceuticals Corp License 1244 Simulect Basiliximab 103764/0 5/12/1998 10 mg/vial 20 mg/vial OMJ Pharmaceuticals, Inc License 1196 Regranex Becaplermin 103691/0 12/16/1997 100 mcg Ortho...
Statistical Evaluation and Review - Rasburicase (Elitek) Date: Type: FDA number: Product/ Application: Indication: Sponsor: Title of Document: From: Through: To: November 282000 BLA 99- 1470 Recombinant urate oxidase enzyme (SR29142) Treatment and prophylaxis of hyperuricemia in patients with leukemia and lymphoma
author: CBER FDA
subject: dob062403
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author: CBER FDA
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author: CBER FDA
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author: CBER FDA
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author: CBER FDA
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author: CBER FDA
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author: CBER FDA
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author: CBER FDA
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author: CBER FDA
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author: CBER FDA
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author: CBER FDA
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author: CBER FDA
subject: dob062403
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author: CBER FDA
subject: dob062403
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author: CBER FDA
subject: dob062403
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author: CBER FDA
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author: CBER FDA
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author: CBER FDA
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author: CBER FDA
subject: dob062403
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author: CBER FDA
subject: dob062403
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author: CBER FDA
subject: dob062403
