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ARTICLE | Company News

FDA approves Santarus' Uceris for ulcerative colitis

January 15, 2013 1:59 AM UTC

Santarus Inc. (NASDAQ:SNTS) said FDA approved Uceris budesonide to induce remission of mild to moderate active ulcerative colitis (UC). The company, which has U.S. rights to the product from Cosmo Pharmaceuticals S.p.A. (SIX:COPN), said it plans to launch Uceris in the U.S. in March. In August, the Netherlands Medicines Evaluation Board decided not to approve an MAA for the product, which is budesonide delivered using Cosmo's MMX multi-matrix system technology. ...