The FDA has approved Apriso (mesalamine extended-release capsules, from Salix) for remission maintenance of ulcerative colitis (UC) in adults. In two randomized, double-blind, placebo-controlled studies involving 562 patients, Apriso was more effective in maintaining long-term UC remission and sustaining improvement of UC symptoms for six months than placebo.

Apriso is expected to launch during the first quarter of 2009 in 0.375g dosage strength.

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