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Uceris (Budesonide) Extended-Release Tablets Launched in U.S. for Treatment of Ulcerative Colitis

Drug approved in January (Feb. 14)

According to a recent announcement, Uceris (budesonide, Santarus, Inc.) extended-release tablets have been launched in the U.S. for the induction of remission in patients with active, mild-to-moderate ulcerative colitis. The drug was approved for this indication on January 14, 2013.

Uceris contains budesonide, a locally acting glucocorticosteroid, in an oral tablet formulation that uses a proprietary colonic delivery technology. The approved dosing regimen for adult patients is one 9-mg tablet taken orally once daily in the morning for up to 8 weeks.

Ulcerative colitis is a form of chronic inflammatory bowel disease (IBD) that produces inflammation and ulcers along the inside of the colon, which can interfere with the colon’s normal function. The disease typically manifests in young adults. Ulcerative colitis is an intermittent disease with periods of exacerbated symptoms, or flares, and periods that are relatively symptom-free. Although the symptoms of ulcerative colitis may resolve without treatment, the disease usually requires medication to go into remission.

According to the Crohn's and Colitis Foundation of America, as many as 700,000 people in the U.S. have the disorder.

Sources: Santarus, Inc.; February 14, 2013; and Uceris PI; January 2013.

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