• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

  • Print
  • Share
  • E-mail
-
 
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
 
-
-