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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 years* Delzicol 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 dosing* New 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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