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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:  12/15/2011
Trade Name:  Nexium
Generic Name or Proper Name (*):  esomeprazole
Indications Studied:  Erosive esophagitis due to acid-mediated gastroesophageal reflux disease
Label Changes Summary:  * Expanded age range to include pediatric patients 1 month to <1 year. Previously approved in 1-17 years. Use in 1 month to <1 year is supported by extrapolation of studies for adults and safety, pharmacokinetic, and pharmacodynamic studies performed in pediatric patients * Safety and effectiveness have not been established in neonates* Information on weight-based dosing, adverse reactions, clinical study
Product Labeling:  Labeling  Opens a new window
BPCA(B) and PREA(P):  B, P
Sponsor:  AstraZeneca
Therapeutic Category:  Antiulcerative