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Santarus NDA For Inflammatory Bowel Disease Therapy Uceris Accepted By FDA

2/15/2012 4:24 AM ET

Santarus Inc. (SNTS: Quote) 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.

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by RTT Staff Writer

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