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

Editors Pick
Apple Inc. (AAPL) reported its third straight quarter of iPhone sales and revenue declines after the market closed on Tuesday. The tech giant's fourth-quarter profit trumped Wall Street expectations, while revenues fell short. Although, Apple reported its third straight year-over-year decline in iPhone... Buick, Lexus and Toyota are among the top brands with highest reliability rating in the latest annual brand reliability survey. A New York woman has filed a $20 million lawsuit against Kentucky Fried Chicken, accusing the fast-food giant of 'false and deceptive trade practice' and also of misleading customers as she did not get enough chicken in her $20 "Fill-Up."
comments powered by Disqus
Follow RTT