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FDA approves drug for irritable bowel syndrome

WASHINGTON, Feb 10 (Reuters) -- US health officials on Wednesday approved Glaxo Wellcome Plc's Lotronex, a drug considered a promising new treatment for millions of Americans with a bowel disorder.

The Food and Drug Administration (FDA) cleared Lotronex for relieving a variety of symptoms caused by irritable bowel syndrome (IBS), an agency spokesperson said.

Lotronex is expected to sell briskly, possibly with sales of $1 billion a year, because IBS affects so many people and current treatments provide only limited relief, industry analysts have said.

IBS causes a range of symptoms including severe abdominal pain, diarrhea and constipation. The severity of the disorder varies, but it can be so serious that it disrupts normal activities, causes people to miss school or work, and forces patients to stay close to a restroom.

The FDA approval means Glaxo will be first to hit the untapped market for IBS treatments, beating other rivals such as the Swiss pharmaceutical firm Novartis AG, which is developing a treatment for IBS known as Zelmac.

Lotronex is considered likely to be one of the most successful new products from British drugs group Glaxo, which has announced plans to merge with SmithKline Beecham to form the world's largest pharmaceutical company.


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