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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:  11/12/2009
 
Trade Name:  Protonix
 
Generic Name or Proper Name (*):  pantoprazole
 
Indications Studied:  GERD
 
Label Changes Summary:  Extended indication from adults to pediatric patients 5 years of age and older Use in pediatric patients 1 to 16 years of age is supported by extrapolation from studies in adults, and safety, efficacy and PK studies performed in pediatric patients There is no age-appropriate formulation available for patients less than 5 years of age Effectiveness was not demonstrated in a clinical trial of patients 1 month to 11 months of age with symptomatic GERD Safety and effectiveness for pediatric uses other than EE have not been established Information on adverse reactions, pharmacokinetics, and clinical studies
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Wyeth
 
Pediatric Exclusivity Granted Date:  02/17/2009
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiulcerative
 
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