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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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