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Ulcerative colitis treatment for children and teens.(Updates)(Salix Pharmaceuticals Inc.)(Brief article)
- Article from:
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FDA Consumer
- Article date:
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March 1, 2007
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Copyright informationCOPYRIGHT 2007 U.S. Government Printing Office. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Colazal (balsalazide disodium) has been approved for the treatment of mildly to moderately active ulcerative colitis in patients ages 5 years to 17 years. This type of bowel disease causes inflammation of the colon and rectum, and affects about 5 per 100,000 children in the United States each year.
Pediatric use of Colazal was granted orphan drug status in December 2006 under the FDA's Orphan Drug program. This program provides financial incentives for firms that develop therapies for diseases affecting fewer than 200,000 patients a year.
Colazal had been previously approved for use in adults with mildly to moderately active ulcerative colitis. The drug's safety and ...