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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
BPCA(B):
B
Sponsor:
OSI Pharmaceuticals, LLC
Pediatric Exclusivity Granted Date:
03/18/2015
NNPS:
FALSE
Therapeutic Category:
Antineoplastic
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