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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:  04/28/2014
 
Trade Name:  Delzicol
 
Generic Name or Proper Name (*):  mesalamine
 
Indications Studied:  Treatment of mildly to-moderately active ulcerative colitis
 
Label Changes Summary:  Approved for use in pediatric patients 12 years and older based on clinical trials conducted with mesalamine 400 mg delayed release tablets which is approved in 5-17 yearsDelzicol is bioequivalent to the mesalamine delayed-release tablets There is no age appropriate Delzicol formulation available for patients less than 12 years Safety and effectiveness of Delzicol in the maintenance of remission of ulcerative colitis in pediatric patients have not been established Information on dosingNew dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Warner Chilcott
 
NNPS:  FALSE'
 
Therapeutic Category:  Anti-Inflammatory
 
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