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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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