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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:  12/12/2018
 
Trade Name:  Exjade; Jadenu
 
Generic Name or Proper Name (*):  deferasirox
 
Indications Studied:  Transfusion-dependent anemia requiring chelation therapy due to iron overload
 
Label Changes Summary:  *A trial conducted in treatment naïve pediatric patients, ages 2 years to less than 18 years with transfusional iron overload did not include a sufficient number of patients to provide additional meaningful information about the safety or compliance of the deferasirox oral tablet for suspension dosage form (Exjade) compared to the deferasirox granules dosage form (Jadenu Sprinkle).
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Novartis
 
NNPS:  FALSE
 
Therapeutic Category:  Iron chelator
 
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