UPDATE 1-Salix says FDA requires additional data on bowel drug

Dec 29 (Reuters) - Salix Pharmaceuticals Ltd (SLXP.O) said U.S. health regulators determined the company's bowel drug application cannot be approved in its present form, and that it requires additional clinical data on the drug.

Shares of the company, which had filed for approval of balsalazide tablets to treat ulcerative colitis in adults, fell 5 percent to $8.50 Monday afternoon on Nasdaq.

The company said it does not intend to conduct additional test for the drug in ulcerative colitis, adding that the data it has provided so far is "sufficient for approval."

Ulcerative colitis is a condition in which the lining of the large intestine becomes inflamed, causing bloody diarrhoea.

Salix said it still sees a loss of about 90 cents a share, excluding items, and total product revenue of about $178 million to $180 million for 2008.

Analysts, on average, were expecting a loss of 91 cents a share, before items, on revenue of $175.9 million, according to Reuters Estimates. (Reporting by Vidya L Nathan in Bangalore; Editing by Deepak Kannan)