NDA Accepted for Uceris for Ulcerative Colitis
Santarus, Inc. announced that the FDA has accepted its New Drug Application (NDA) for Uceris (budesonide) tablets 9mg for the induction of remission of mild to moderate active ulcerative colitis.
Uceris is an investigational drug that is a locally acting (non-systemic) corticosteroid in a novel, patented, oral tablet formulation, which uses proprietary MMX® multi-matrix system technology and is designed to result in the controlled release and distribution of budesonide throughout the length of the colon. Budesonide has topical anti-inflammatory activity, and due to an extended first pass effect, has less systemic absorption than other corticosteroids.
For more information, call (858) 314-5700 or visit www.santarus.com.