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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:
01/23/2013
Trade Name:
Exjade
Generic Name or Proper Name (*):
deferasirox
Indications Studied:
Treatment of chronic iron overload in patients with non-transfusion dependent thalassemia
Label Changes Summary:
Approved for use in 10 years and older for NTDT Safety and effectiveness have not been established in pediatric patients less than 10 years Information on dosing, adverse reactions in adults and pediatric patients, and clinical trials New indication
Product Labeling:
Labeling
;
Labeling
PREA(P):
P
Sponsor:
Novalar Pharmaceuticals, Inc.
NNPS:
FALSE'
Therapeutic Category:
Iron chelator
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