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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 patients*Safety and effectiveness in pediatric patients below 5 years have not been established*Safety and effectiveness for the maintenance of remission of ulcerative colitis in pediatric patients have not been established*Adverse reactions in the pediatric population were similar to those reported in adults*Information on dose, adverse reactions, PK and clinical trials*Postmarketing study
Product Labeling:  Labeling  Opens a new window
BPCA(B) and PREA(P):  B,P
Sponsor:  Warner Chilcott
Therapeutic Category:  Anti-inflammatory