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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
BPCA(B):
B
Sponsor:
Warner Chilcott
NNPS:
FALSE
Therapeutic Category:
Anti-inflammatory
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