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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:  10/18/2013
 
Trade Name:  Asacol
 
Generic Name or Proper Name (*):  mesalamine***
 
Indications Studied:  Treatment of mildly to moderately active ulcerative colitis
 
Label Changes Summary:  Safety and effectiveness in pediatric patients 5 - 17 years have been established over a 6-week period. Use in this age group is supported by evidence from studies in adults and 1 study in pediatric patientsSafety and effectiveness in pediatric patients below 5 years have not been establishedSafety and effectiveness for the maintenance of remission of ulcerative colitis in pediatric patients have not been establishedAdverse reactions in the pediatric population were similar to those reported in adultsInformation on dose, adverse reactions, PK and clinical trialsPostmarketing study
 
Product Labeling:    Opens a new window
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  Warner Chilcott
 
NNPS:  FALSE
 
Therapeutic Category:  Anti-inflammatory
 
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