ARTICLE | Clinical News

Uceris budesonide rectal foam regulatory update

October 6, 2014 7:00 AM UTC

FDA granted tentative approval to an NDA for Uceris budesonide rectal foam from Salix for the induction of remission of mild to moderate distal ulcerative colitis (UC) extending up to 40 cm from the anal verge. The company expects to receive final approval of the foam formulation of budesonide -- a glucocorticosteroid -- upon resolution of patent issues. Salix expects to resolve the issues early this quarter and launch Uceris rectal foam in 1Q15. 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. ...