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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:  09/02/2016
 
Trade Name:  Canasa Suppositories
 
Generic Name or Proper Name (*):  mesalamine
 
Indications Studied:  Mildly to moderately active ulcerative proctitis
 
Label Changes Summary:  *Safety and effectiveness in pediatric patients have not been established. *Canasa was evaluated for the treatment of ulcerative proctitis in a 6-week, open-label, single-arm study in 49 patients 5 to 17 years of age. *Adverse reactions were similar to those seen in adult patients. *Information on adverse reactions, and clinical trial. *Postmarketing study.
 
PREA(P):  P
 
Sponsor:  Forest
 
NNPS:  FALSE
 
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