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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:  04/28/2006
 
Trade Name:  Nexium
 
Generic Name or Proper Name (*):  esomeprazole
 
Indications Studied:  Short-term treatment of GERD
 
Label Changes Summary:  Use in adolescent patients 12 to 17 years of age is supported by extrapolation from studies in adults, and safety and PK studies performed in adolescent patients Safety and effectiveness in patients < 12 years has not been established Safety and effectiveness for other pediatric uses have not been established Information on dose, treatment related AEs, clinical study
 
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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