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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:
05/15/2019
Trade Name:
Gattex
Generic Name or Proper Name (*):
teduglutide
Indications Studied:
Short Bowel Syndrome (SBS) in pediatric patients 1 year of age and older
Label Changes Summary:
*Safety and effectiveness of Gattex have been established in pediatric patients 1 year to less than 17 years of age who are dependent on parenteral support for the treatment of SBS. *Use of Gattex in this population is supported by evidence from adequate and well-controlled studies in adults, with additional efficacy, safety, pharmacokinetic and pharmacodynamic data in pediatric patients 1 year to less than 17 years of age. There were 41 pediatric patients treated with Gattex: 1 infant (1 year to less than 2 years), 37 children (2 years to less than 12 years) and 3 adolescents (12 years to less than 17 years). *Safety and effectiveness in pediatric patients less than 1 year of age have not been established. *Adverse reactions in pediatric patients were similar to those seen in adults. *Information on dosing, adverse reactions, PK parameters and clinical trials.
PREA(P):
P
Sponsor:
Shire-NPS Pharmaceuticals, Inc.
NNPS:
FALSE
Therapeutic Category:
Glucagon-like peptide-2 (GLP-2) analog
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