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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:  04/29/2016
 
Trade Name:  Entocort EC
 
Generic Name or Proper Name (*):  budesonide
 
Indications Studied:  Treatment of mild to moderate active Crohn's disease in patients 8 years of age and older, and maintenance of remission in Crohn’s disease in patients ages zero to 17 years of age
 
Label Changes Summary:  Mild to moderate active Crohn's disease * Safety and effectiveness have been established in pediatric patients 8 to 17 years who weigh more than 25 kg for the treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon. * Use in this age group is supported by evidence from adequate and well controlled studies of Entocort EC in adults, with additional data from 2 clinical studies in 149 pediatric patients treated up to 8 weeks and one pharmacokinetic study in 8 pediatric patients. * Safety and effectiveness have not been established in pediatric patients less than 8 years of age. Maintenance of remission in Crohn’s disease * Safety and effectiveness have not been established in pediatric patients for the maintenance of clinical remission of mild to moderate Crohn’s disease. * An open-label study to evaluate the safety and tolerability as maintenance treatment in pediatric patients aged 5 to 17 years did not establish the safety and efficacy of maintenance of clinical remission. * Safety profile is similar to safety profile observed in adults and no new safety concerns were identified. * Systemic corticosteroids, including Entocort EC, may cause a reduction of growth velocity in pediatric patients. * Pediatric patients with Crohn’s disease have a 17% higher mean systemic exposure and cortisol suppression than adults with Crohn’s disease. *Information on dosing, safety, clinical trials and PK. *Postmarketing study.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Elan
 
NNPS:  FALSE
 
Therapeutic Category:  Anti-inflammatory
 
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