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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:  05/27/2015
 
Trade Name:  Asacol
 
Generic Name or Proper Name (*):  mesalamine***
 
Indications Studied:  Maintenance of remission of mildly to moderately active ulcerative colitis
 
Label Changes Summary:  *Safety and effectiveness for the maintenance of remission of mildly to moderately active ulcerative colitis in pediatric patients have not been established *Efficacy was not demonstrated in a randomized, double-blind 26-week trial of two dosage levels in 39 patients aged 5 to 17 years
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Warner Chilcott
 
NNPS:  FALSE
 
Therapeutic Category:  Anti-inflammatory
 
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