ARTICLE | Clinical News
Uceris budesonide rectal foam regulatory update
October 13, 2014 7:00 AM UTC
FDA granted final approval to Uceris budesonide rectal foam from Salix for the induction of remission in patients with active, mild to moderate distal ulcerative colitis (UC) extending up to 40 cm from the anal verge. FDA granted tentative approval to the foam formulation of budesonide -- a glucocorticosteroid -- on Sept. 15, pending resolution of patent issues. Salix plans to launch the product next quarter. Salix markets a once-daily tablet formulation of Uceris in the U.S. for the induction of remission in patients with active, mild to moderate UC. ...