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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:
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:
BPCA(B) and PREA(P):
B,P
Sponsor:
Warner Chilcott
NNPS:
FALSE
Therapeutic Category:
Anti-inflammatory
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