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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:  01/23/2013
 
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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Novalar Pharmaceuticals, Inc.
 
NNPS:  FALSE'
 
Therapeutic Category:  Iron chelator
 
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