FDA approves Colazal for pediatric patients

February 16, 2007

In December, the U.S. Food and Drug Administration (FDA) approved the use of Zolazal (balsalazide disodium) capsules 750 mg in pediatric patients between 5 to 17 years of age with ulcerative colitis. Colazal, an anti-inflammatory drug approved for the treatment of mildly to moderately active ulverative colitis, is manufactured by Salix Pharmaceuticals, Ltd.

In December, the U.S. Food and Drug Administration (FDA) approved the use of Zolazal (balsalazide disodium) capsules 750 mg in pediatric patients between 5 to 17 years of age with ulcerative colitis. Colazal, an anti-inflammatory drug approved for the treatment of mildly to moderately active ulverative colitis, is manufactured by Salix Pharmaceuticals, Ltd.

"We believe this approval speaks, in large part, to the tolerability of our unique, ago-bonded pro drug formulation of 5-ASA, which is specifically designed for 99% delivery of 5-ASA directly to the colon," commented Carolyn Logan, Salix Pharmaceuticals' president and c.e.o. "This approval, combined with the September labeling approval which provides for the administration of Colazal as sprinkled over applesauce, should provide gastroenterologists with an option that increases their level of comfort and confidence in treating children."