On May 5th, the FDA posted a letter sent to Shire Development, Inc. regarding the marketing of LIALDA, an oral sustained release multimatrix formulation of mesalazine approved in 2007. LIALDA is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. The Warning Letter stated that a brochure used by Shire to market LIALDA is false or misleading because it overstates the efficacy of LIALDA, contains unsubstantiated superiority claims, omits risk information associated with the drug, broadens the indication of the drug, and contains unsubstantiated claims. LIALDA has been used off–label for other lower GI tract conditions, such as Crohn’s disease, general bowel infection and abdominal pain.
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