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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:  12/20/2006
 
Trade Name:  Colazal
 
Generic Name or Proper Name (*):  balsalazide
 
Indications Studied:  Mildly to moderately active ulcerative colitis in patients 5 years of age and older
 
Label Changes Summary:  Extended indication from adults to patients 5 years and older Dosing can be initiated at either 6.75 or 2.25 g/day PK of balsalazide, and metabolites showed very large inter-patient variability similar to that seen in adults AEs were similar to those seen in adults
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Salix
 
Pediatric Exclusivity Granted Date:  08/23/2006
 
NNPS:  FALSE'
 
Therapeutic Category:  Gastroenterology
 
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