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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  01/13/2003
 
Trade Name:  Busulfex
 
Generic Name or Proper Name (*):  busulfan
 
Indications Studied:  Part of a conditioning regimen administered prior to hematopoietic progenitor cell transplantation for a variety of malignant hematologic or non-malignant diseases
 
Label Changes Summary:  * The population pharmacokinetic estimates of busulfan for clearance and volume of distribution were determined in an open-label, uncontrolled PK study in 24 pediatric patients 5 months to 16 years who received busulfan as part of a conditioning regimen administered prior to hematopoietic progenitor cell transplantation for a variety of malignant hematologic or non-malignant diseases * Suggested dosing regimen
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Orphan Medical
 
Pediatric Exclusivity Granted Date:  03/12/2002
 
NNPS:  FALSE
 
Therapeutic Category:  Antineoplastic
 
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