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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:  07/08/2016
 
Trade Name:  Dexilant
 
Generic Name or Proper Name (*):  dexlansoprazole
 
Indications Studied:  Healing of erosive esophagitis (EE), maintenance of healed EE and relief of heartburn, and treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD) in 12 to 17 years
 
Label Changes Summary:  *Safety and effectiveness of Dexilant capsules have been established in pediatric patients 12 to 17 years for the healing of all grades of EE. *The safety and effectiveness of Dexilant capsules and Dexilant SoluTab have been established in pediatric patients 12 to 17 years for the maintenance of healed EE and relief of heartburn, and treatment of heartburn associated with symptomatic non-erosive GERD. *Use in this age group is supported by evidence from adequate and well-controlled studies of Dexilant capsules in adults with additional safety, efficacy and pharmacokinetic data in pediatric patients 12 to 17 years. *Safety and effectiveness have not been established in pediatric patients less than 12 years. *Use of Dexilant is not recommended for symptomatic non-erosive GERD in pediatric patients less than 1 year because studies in this class of drugs have not demonstrated efficacy. *Adverse reactions similar to those observed in adults. *Information on dosing, adverse reactions, clinical trials. *Postmarketing study.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Takeda
 
NNPS:  FALSE
 
Therapeutic Category:  Antiulcerative
 
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