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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:  04/27/2015
 
Trade Name:  Tarceva
 
Generic Name or Proper Name (*):  erlotinib
 
Indications Studied:  Recurrent or refractory ependymoma
 
Label Changes Summary:  *Safety and effectiveness in pediatric patients have not been established. * In an open-label, multi-center trial, 25 pediatric patients (median age 14 years, range 3-20 years) with recurrent or refractory ependymoma were randomized to Tarceva or etoposide. * Safety and effectiveness in pediatric patients have not been established. * In an open-label, multi-center trial, 25 pediatric patients (median age 14 years, range 3-20 years) with recurrent or refractory ependymoma were randomized to Tarceva or etoposide. * The trial was terminated prematurely for lack of efficacy. * No new adverse events were identified in the pediatric population. * Information on clinical trial and population pharmacokinetics
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  OSI Pharmaceuticals, LLC
 
Pediatric Exclusivity Granted Date:  03/18/2015
 
NNPS:  FALSE
 
Therapeutic Category:  Antineoplastic
 
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