Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
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
BPCA(B) and PREA(P):
B, P
Sponsor:
Salix
Pediatric Exclusivity Granted Date:
08/23/2006
NNPS:
FALSE'
Therapeutic Category:
Gastroenterology
-
-