Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
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
BPCA(B):
B
Sponsor:
AstraZeneca
Pediatric Exclusivity Granted Date:
05/01/2009
NNPS:
FALSE'
Therapeutic Category:
Antiulcerative
-
-