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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
BPCA(B):
B
Sponsor:
Orphan Medical
Pediatric Exclusivity Granted Date:
03/12/2002
NNPS:
FALSE'
Therapeutic Category:
Antineoplastic
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