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FDA Approves Once-Daily Mesalamine for Ulcerative Colitis

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Shire received approval from the FDA for Lialda (mesalamine) with MMX technology, indicated for patients with active mild-to-moderate ulcerative colitis. Lialda is the only FDA-approved once-daily oral formulation of mesalamine. Shire will launch the drug in the U.S. in 1Q2007. Other currently available mesalamines require three to four doses daily of 6 to 16 pills. A recent study conducted by the Crohn’s and Colitis Foundation of America (CCFA) found that 65% of patients with ulcerat...

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