FDA Approves Santarus' UCERIS for Induction of Remission in Patients with Active, Mild to Moderate Ulcerative Colitis

Santarus SNTS announced today that the U.S. Food and Drug Administration (FDA) has approved UCERIS™ (budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis. The company expects to commence the commercial launch of UCERIS in March 2013. UCERIS contains budesonide, a corticosteroid, in a novel oral tablet formulation that utilizes proprietary MMX® multi-matrix system colonic delivery technology. The approved dosing regimen for adult patients is one 9 mg tablet taken orally once daily in the morning for up to 8 weeks. UCERIS was developed in collaboration with Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals S.p.A. See full press release