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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:  05/13/2010
 
Trade Name:  Taxotere
 
Generic Name or Proper Name (*):  docetaxel
 
Indications Studied:  Solid Tumors
 
Label Changes Summary:  Efficacy in pediatric patients as monotherapy or in combination has not been established. Taxotere has been studied in a total of 289 pediatric patients: 239 in 2 trials with monotherapy and 50 in combination treatment with cisplatin and 5-fluoruracil The overall safety profile in pediatric patients receiving monotherapy or combination treatment was consistent with the safety profile in adults Information on dosing, clinical trials and PK parameters
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Sanofi-Aventis
 
Pediatric Exclusivity Granted Date:  03/17/2010
 
NNPS:  FALSE'
 
Therapeutic Category:  Antineoplastic
 
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