Final Approval of Uceris Rectal Foam for Ulcerative Colitis Granted by FDA
Salix announced that the Food and Drug Administration (FDA) has granted final approval for Uceris (budesonide) 2mg rectal foam for the induction of remission in patients with active mild-to-moderate distal ulcerative colitis (UC) extending up to 40cm from the anal verge.
Budesonide is a high potency corticosteroid, developed to minimize the systemic adverse consequences of classic corticosteroids, which have higher levels of systemic absorption. Clinical trials suggest that the foam formulation demonstrates improved reach and rapid distribution of budesonide to the sigmoid colon and the rectum, without the difficulties and inconvenience associated with retention of enema formulations. These trials also suggest that the foam provides more immediate and targeted therapy for distal ulcerative colitis compared to oral therapies.
Uceris rectal foam received tentative FDA approval on September 15 pending resolution of patent issues. The FDA final approval is following the 45-day waiting period described in section 505(c)(3)(C) of the Federal Food, Drug and Cosmetic Act.
Uceris is currently available as a 9mg extended-release tablets indicated for the induction of remission in patients with active, mild-to-moderate ulcerative colitis.
For more information call (800) 508-0024 or visit Uceris.com.