• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

  • Print
  • Share
  • E-mail
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
Sponsor:  AstraZeneca
Pediatric Exclusivity Granted Date:  05/01/2009
Therapeutic Category:  Antiulcerative