FDA Approved Medical Products for:

Pediatric ulcerative colitis

The table(s) below may not be an exhaustive list of drugs or products used to treat this condition. There may be other products available that are not considered orphan products.

Generic Name Balsalazide disodium
Trade Name
(Manufacturer Name)
Colazal®
(Salix Pharmaceuticals, Inc.)
Indication
The FDA has approved this product to be used in this manner.
Treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. Safety and Effectiveness of Colazal beyond 8 weeks in children (ages 5-17) and 12 weeks in adults have not been established.
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Generic Name Infliximab
Trade Name
(Manufacturer Name)
Remicade
(Janssen Biotech)
Indication
The FDA has approved this product to be used in this manner.
For reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.
More Information about this product Drug Information Portal
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