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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:  05/15/2019
 
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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