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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:  03/11/2003
 
Trade Name:  Temodar
 
Generic Name or Proper Name (*):  temozolomide
 
Indications Studied:  Recurrent CNS tumors
 
Label Changes Summary:  * Temozolomide effectiveness in children has not been demonstrated * New data from 2 open-label Phase 2 studies in pediatric patients 3-18 years of age. In one study there were 29 patients with recurrent brain stem glioma and 34 patients with recurrent high grade astrocyoma. In a second study there were 122 patients enrolled with various types of tumors; 113 CNS tumors and 9 non-CNS tumors. * The temozolomide toxicity profile in children is similar to adults
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Schering
 
Pediatric Exclusivity Granted Date:  11/20/2002
 
NNPS:  FALSE
 
Therapeutic Category:  Antineoplastic
 
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