logo
Share SHARE
FONT-SIZE Plus   Neg

Santarus NDA For Inflammatory Bowel Disease Therapy Uceris Accepted By FDA

Santarus Inc. (SNTS) Wednesday reported that the United States Food and Drug Administration, or FDA, accepted for filing its New Drug Application, or NDA, seeking approval to market Uceris tablets as a therapy to induce remission of mild to moderate active ulcerative colitis. The company anticipates the completion of the FDA's review by mid-October 2012.

The NDA seeks to market Uceris in a 9 milligram, or mg, tablet. Also, Cosmo Pharmaceuticals SpA-owned Cosmo Technologies Ltd., a collaborator in the development of Uceris, is now eligible to $4 million in cash or stock as a milestone payment, Santarus Said.

A form of inflammatory bowel disease, or IBD, ulcerative colitis can cause inflammations and ulcers along the colon, resulting in such effects as diarrhea, frequent bowel movements and bleeding. About 1.4 million Americans suffer from IBDs. Uceris is the trade name for budesonide, which is a corticosteroid with topical anti-inflammatory properties.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
HSBC is reportedly laying off about 100 of its senior investment bankers worldwide, as the banking giant strives to curb operating costs. According to reports, the London-headquartered bank will eliminate managing director and director level employees at the Global Banking and Markets division, as... Samsung Electronics Co., Ltd. (SMSN.L, SSNNF.OB, SSNLF.OB) will reportedly blame faulty batteries for last year's Galaxy Note 7 fiasco. According to a Wall Street Journal report, Samsung's investigation of Galaxy Note 7 smartphones found that some batteries were irregularly sized while others had... Federal investigators have closed their probe of a fatal crash that involved a Tesla Motors Inc. car eight months ago. The regulators said they have found no safety defects in the vehicle's automated driving system and that Tesla's Autopilot-enabled vehicles did not need to be recalled.
comments powered by Disqus
Follow RTT