Novartis's Zelnorm Enters Restricted Access Program

Law360, New York (July 27, 2007, 12:00 AM EDT) -- A few months after the U.S. Food and Drug Administration ordered it pulled from the market amid concerns about causing heart problems, Novartis AG's controversial drug Zelnorm will return under a restricted access program, announced the FDA and Novartis Friday.

The FDA has approved Zelnorm as a treatment investigational new drug. Women younger than 55 who suffer from either bowel syndrome with constipation or chronic idiopathic constipation for whom a doctor deems the drug medically necessary may consent to receive it, according to the FDA and...
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