Delzicol (mesalamine, Warner Chilcott) is intended to treat mild-to-moderate ulcerative colitis (UC) and maintenance of remission. The drug will be available in 400-mg, delayed-release capsules, with an approved dosage of 800 mg three times a day for treatment and a divided dose of 1.6 g per day for maintenance of remission, according to the release. The company will launch Delzicol commercially during March.
Approval for Delzicol followed two placebo-controlled studies assessing its use as a treatment for UC, in which divided daily doses of 2.4 g and 4.8 g resulted in significant improvement to the sigmoidoscopic appearance of the bowel compared with placebo
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FDA approves Delzicol to treat ulcerative colitis
The FDA has approved Delzicol as a treatment for ulcerative colitis, according to a press release. Delzicol (mesalamine, Warner Chilcott) is intended to treat mild-to-moderate ulcerative colitis (UC) and maintenance of remission. The drug will be …
Warner Chilcott Announces FDA Approval of New Ulcerative Colitis Product GlobeNewswire (press release)all 3 news articles »