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