FDA denies Salix ulcerative colitis drug approval
By
Associated Press
December 29, 2008
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Salix Pharmaceuticals Ltd. said Monday the Food and Drug Administration denied approval for the company's ulcerative colitis treatment and said a new study would be needed for another application.
In a statement, the company disagreed with the FDA, saying it believes the current application for the balsalazide tablet is sufficient.
Ulcerative colitis is a condition that causes ulcers in the rectum and colon lining.
Salix plans on meeting with the FDA to discuss its options, but does not plan on conducting an additional study. It reaffirmed its 2008 outlook for a loss of 90 cents per share on revenue between $178 million and $180 million.
Analysts polled by Thomson Reuters expect a loss of 90 cents per share on revenue of $175.9 million.
Shares of Salix fell 43 cents, or 4.8 percent, to $8.50 in afternoon trading. The stock has traded between $5.07 and $10.47 over the last 52 weeks.
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