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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:
09/09/2015
Trade Name:
Delzicol
Generic Name or Proper Name (*):
mesalamine**
Indications Studied:
Treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older
Label Changes Summary:
*Expanded the indication to pediatric patients 5 years and older; previously approved in 12 years and older. *Safety and effectiveness in pediatric patients below the age of 5 years have not been established. *Two Delzicol 400 mg capsules have not been shown to be interchangeable or substitutable with one mesalamine delayed-release 800 mg tablet. *For patients unable to swallow the capsules whole, information on opening the capsule(s) and swallowing the contents. *New dosage form
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
Warner Chilcott
NNPS:
FALSE
Therapeutic Category:
Anti-inflammatory
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