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...
To view the full article, register now.

Law360 UK

UK Financial Services

Read Our Latest UK Legal News & Analysis

Financial Services Law360 UK and Insurance Law360 UK provide breaking news and in-depth analysis on U.K. and European Union regulation, enforcement, legislation, and litigation involving banks, investment firms, insurers, and more.