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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:  01/10/2007
 
Trade Name:  Eloxatin
 
Generic Name or Proper Name (*):  oxaliplatin
 
Indications Studied:  Solid tumors
 
Label Changes Summary:  * The effectiveness of oxaliplatin in children has not been established * No significant activity observed in 2 Phase I and 2 Phase II trials in 159 patients ages 7 months to 22 years with solid tumors * Information on clinical studies and AEs
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Sanofi-Aventis
 
Pediatric Exclusivity Granted Date:  09/27/2006
 
NNPS:  FALSE
 
Therapeutic Category:  Antineoplastic
 
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