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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:  12/10/2013
 
Trade Name:  Xeloda
 
Generic Name or Proper Name (*):  capecitabine
 
Indications Studied:  Newly diagnosed brainstem gliomas and high grade gliomas
 
Label Changes Summary:  *The safety and effectiveness in pediatric patients have not been established *No clinical benefit was demonstrated in 2 single arm trials in pediatric patients* The adverse reaction (AR) profile was consistent with the known AR profile in adults, with the exception of laboratory abnormalities which occurred more commonly in pediatric patients* Information on dosing, adverse reactions, and clinical trials
 
Product Labeling:  Labeliong  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Hoffman- LaRoche
 
NNPS:  FALSE
 
Therapeutic Category:  Antineoplastic
 
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