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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:  06/18/2009
Trade Name:  Nexium
Generic Name or Proper Name (*):  esomeprazole
Indications Studied:  Short-term treatment of GERD
Label Changes Summary:  * Effectiveness was not demonstrated in a randomized, placebo-controlled study in neonates to < 1 year * Information on clinical study, PK/PD parameters
Product Labeling:  Labeling'  Opens a new window
BPCA(B) and PREA(P):  B, P
Sponsor:  AstraZeneca
Pediatric Exclusivity Granted Date:  05/01/2009
Therapeutic Category:  Antiulcerative