Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
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
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiulcerative
 
-
-