The Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Delzicol (mesalamine; Warner Chilcott) delayed-release capsules for the treatment of mildly to moderately active ulcerative colitis in patients ≥5 years of age.
Delzicol, an aminosalicylate, was previously approved for use in patients aged ≥12 years old. The exact mechanism of action of mesalamine is unknown, but it appears to be topical rather than systemic. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways, that is, prostanoid, and through the lipoxygenase pathways, that is, leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with chronic ulcerative colitis, and it is possible that mesalamine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.
Delzicol is available as 400mg delayed-release capsules in 180-count bottles.
For more information call (800) 272-5525 or visit Delzicol.com.