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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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Pediatric Labeling Date:
03/26/2013
Trade Name:
Aciphex
Generic Name or Proper Name (*):
rabeprazole
Indications Studied:
Gastroesophageal reflux
Label Changes Summary:
Expanded the indication to pediatric patients down to 1 year; previously approved in pediatric patients 12 years and older Studies do not support the use in pediatric patients < 1 year Use in neonates is strongly discouraged based on the risk of prolonged acid suppression and lack of demonstrated safety and effectiveness in neonates Adverse reactions were similar to those observed in adults and adolescents Information on clinical studies, dosing, population PK in neonates, and adverse reaction
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B,P
Sponsor:
Eisai Medical Research
Pediatric Exclusivity Granted Date:
12/04/2012
NNPS:
FALSE'
Therapeutic Category:
Antiulcerative
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