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Salix Pharmaceuticals, Ltd. (SLXP) Announces Acceptance Of NDA Filing For Budesonide Foam In Patients With Distal Ulcerative Colitis



1/30/2014 11:55:33 AM

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RALEIGH, N.C.--(BUSINESS WIRE)--Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Food and Drug Administration (FDA) has accepted for filing a New Drug Application (NDA) for Budesonide 2 mg Rectal Foam for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge. The FDA has issued an action date of September 15, 2014 under the Prescription Drug User Fee Act (PDUFA). Bill Forbes, Executive Vice President, Medical and Research and Development and Chief Development Officer, Salix, stated, “Patients with distal ulcerative colitis, also known as proctitis or proctosigmoiditis, are often difficult to treat and present the most challenging subset of patients given the limitations of available treatment options. For these patients with disease limited to the rectum and sigmoid areas of the colon, treatment with currently approved oral therapies is often ineffective due to insufficient distribution of active drug to the distal colon. Distal ulcerative colitis remains an unmet medical need, and we believe the availability of a rectally administered corticosteroid such as budesonide foam may help overcome limitations of existing products to treat this condition.”

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