Santarus has obtained FDA approval for ulcerative colitis therapy, Uceris (budesonide) extended release tablets.
A 9mg dose tablet is approved for administration once a day in adult patients with ulcerative colitis for up to eight weeks.
The company anticipates launching Uceris, indicated for the induction of remission in patients suffering from active, mild to moderate ulcerative colitis, in March 2013.
Oral tablet formulation of Uceris contains budesonide and leverages MMX multi-matrix system colonic delivery technology.
Santarus president and CEO Gerald Proehl said the company provides new option for patients to treat the active phase of mild to moderate ulcerative colitis.
"With the incremental revenue from UCERIS and continued growth in our marketed products, we anticipate another robust year of solid financial results for Santarus in 2013," Proehl added.
"We expect total revenues of $320 million to $325 million, representing significant double-digit growth over our 2012 revenue guidance."
Santarus developed Uceris in collaboration with Cosmo Technologies, a subsidiary of Cosmo Pharmaceuticals.
