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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
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiulcerative
 
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