Novartis Makes Drug Available Only In Dire Situations

Law360, New York (April 3, 2008, 12:00 AM EDT) -- Novartis Pharmaceuticals Corp. will make Zelnorm, its drug for irritable bowel syndrome with constipation, available to patients only in emergency situations, the U.S. Food and Drug Administration announced Wednesday.

The FDA said that requests for Zelnorm from now on can be made directly to the agency, which defines an emergency situation as one that is immediately life-threatening or serious enough to qualify for hospitalization.

In March 2007, the FDA asked Novartis to stop selling and marketing the treatment in the U.S. after a safety analysis found...
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