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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:  02/27/2008
 
Trade Name:  Nexium
 
Generic Name or Proper Name (*):  esomeprazole
 
Indications Studied:  Short-term treatment of GERD
 
Label Changes Summary:  Expanded age range to include pediatric patients 1-11 years. Previously approved in 12-17 years Use in pediatric patients 1 to 17 years of age is supported by extrapolation from studies in adults, and safety and PK studies performed in pediatric and adolescent patients Safety and effectiveness in pediatric patients <1 year of age have not been established Safety and effectiveness for other pediatric uses have not been established Information on dose, treatment related adverse events (AEs), clinical study New formulation
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  AstraZeneca
 
Pediatric Exclusivity Granted Date:  05/01/2009
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiulcerative
 
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