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
Costco Wholesale Corp. (COST), an international chain of membership warehouses, is scheduled to report its first-quarter results on Thursday. Analysts polled by Thomson Reuters estimate earnings of $1.34 per share on revenue of $31.47 billion. Last year, the company reported earnings of $1.24 per share and revenue of $28.1 billion. Shares of Industria de Diseño Textil SA or Inditex were gaining around 4 percent in the morning trading in Spain after the fashion retailer reported Wednesday higher profit and sales in the nine-month period. Regarding the fourth-quarter 2017 trading, the company noted that online and offline store sales increased 13 percent in local currency terms between November 1 and December 11. PepsiCo has placed reservations for 100 Tesla Semi trucks, reports said. The order booking, which is said to be the largest public one to date, is likely to cost the snack and beverage giant around $2 million. Tesla's electric commercial trucks is expected to begin production in 2019. It requires $20,000 for reservation for a truck, as per reports.
comments powered by Disqus
Follow RTT