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US FDA Seems Ready For Return Of Zelnorm, But Seeks Advice On Best Subpopulation

Executive Summary

Whether Sloan Pharma's irritable bowel constipation drug tegaserod should be indicated only for women at low cardiovascular risk, women who are severely symptomatic, or women who fall into both categories is a question for FDA's Gastrointestinal Drugs Advisory Committee; panel also is asked to discuss risk of psychiatric adverse events with the 5-HT4 receptor agonist.

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