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FDA approves Uceris as ulcerative colitis treatment
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The FDA has approved the use of Uceris to induce remission of ulcerative colitis, according to a company press release.
Uceris (budesonide, Santarus Inc., Cosmo Technologies) is a corticosteroid intended for use in adult patients with active, mild to moderate ulcerative colitis. The extended release 9 mg tablets have been approved to be taken once daily for up to 8 weeks, and will be launched commercially in March.
Common side effects related to Uceris include headache, nausea, bloating, acne, urinary tract infection, joint and stomach pain, constipation, tiredness and a decrease in blood cortisol levels, according to the release. Long-time use also can cause hypercorticism and result in insufficient production of steroid hormones.
“The FDA approval of Uceris provides an important new therapeutic option to patients and physicians for the treatment of active, mild to moderate ulcerative colitis,” William J. Sandborn, MD, chief of the gastroenterology division and professor of clinical medicine at the University of California San Diego Health System, said in the release.