Santarus Submits New Drug Application to FDA for UCERIS Tablets

Santarus, Inc.

today announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration seeking market approval for UCERIS Tablets 9 mg for the induction of remission of mild to moderate active ulcerative colitis. UCERIS, a locally acting, nonsystemic corticosteroid in a novel, patented, oral tablet formulation, utilizes proprietary MMX^ multi-matrix system technology that is designed to result in the controlled release and distribution of budesonide throughout the length of the colon. UCERIS is being developed in collaboration with Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals S.p.A.