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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
Sponsor:  AstraZeneca
Pediatric Exclusivity Granted Date:  05/01/2009
Therapeutic Category:  Antiulcerative