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