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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
Therapeutic Category:  Gastroenterology