FDA rejects Novartis drug
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June 18, 2001: 8:26 p.m. ET
FDA refuses to approve Novartis/BMY irritable bowel syndrome treatment
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NEW YORK (CNNfn) - The U.S. Food and Drug Administration failed to approve a Novartis and Bristol-Myers Squibb drug for the treatment of irritable bowel syndrome.
Novartis said Monday the FDA requested more data about IBS treatment Zelnorm. The company said it is considering options, along with Bristol-Myers (BMY: Research, Estimates).
There is currently no effective treatment for IBS, Novartis said.
Dain Rauscher Wessels said in a research note it does not expect Zelnorm to be approved before 2003 if a new study is required and maintained its "neutral" rating on Bristol-Myers.
Shares of Bristol-Myers lost 44 cents to $55.06 Monday.
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