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FDA Approves Delzicol (Mesalamine) for Ulcerative Colitis

Launch expected in March (Feb. 5)

The FDA has approved a new 400-mg mesalamine product for the treatment of ulcerative colitis. The drug will be marketed as Delzicol (mesalamine, Warner Chilcott) 400-mg delayed-release capsules. The commercial launch is expected in March 2013.

Delzicol (mesalamine) is an aminosalicylate — a nonsteroidal anti-inflammatory agent — indicated for the treatment of mildly to moderately active ulcerative colitis and for the maintenance of remission of ulcerative colitis.

According to the product labeling, the mechanism of action of mesalamine is unknown, but the drug appears to act topically rather than systemically. Mucosal production of arachidonic acid metabolites — both through the cyclooxygenase pathways (that is, prostanoids) and through the lipoxygenase pathways (that is, leukotrienes and hydroxyeicosatetraenoic acids) — is increased in patients with chronic ulcerative colitis, and mesalamine may diminish inflammation by blocking cyclooxygenase and by inhibiting prostaglandin production in the colon.

For the treatment of mildly to moderately active ulcerative colitis, the recommended dosage of Delzicol (mesalamine) in adults is two 400-mg capsules three times daily for 6 weeks. For the maintenance of remission of ulcerative colitis, the recommended dose in adults is 1.6 g daily in divided doses. Delzicol should be dosed at least 1 hour before a meal or 2 hours after a meal.

Sources: Warner Chilcott; February 5, 2013; and Delzicol PI; February 2013.

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