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.
For comments and feedback contact: editorial@rttnews.com
Business News
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.