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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:  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  Opens a new window
BPCA(B) and PREA(P):  B,P
Sponsor:  Eisai Medical Research
Pediatric Exclusivity Granted Date:  12/04/2012
Therapeutic Category:  Antiulcerative