Healthy Skepticism Library item: 10312

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Publication type: news

Swiss medical watchdog orders Novartis' Zelnorm/Zelmac market withdrawal
Hemscott 2007 May 31
http://www.hemscott.com/news/latest-news/item.do?newsId=44545253450470

Full text:

ZURICH (Thomson Financial) – Swiss medical watchdog Swissmedic said it had ordered a market withdrawal for Novartis AG’s irritable bowel syndrome drug Zelnorm/Zelmac, after the US Food and Drug Administration (FDA) ordered a withdrawal earlier this year.

‘Swissmedic has refused to extend the licence as the risks are greater than the benefit,’ the Swiss medical authority said.

The decision comes after a fresh analysis of the data from clinical studies revealed an increased risk of cardiovascular conditions, Swissmedic said.

In March this year Swissmedic already issued new administration recommendations after the FDA withdrew the drug from the market.

Following US market withdrawal, Novartis revised its target for 2007 group net sales growth to ‘above 5 pct’ from its previous guidance for mid- to high-one-digit percentage growth.

Zelnorm sales reached 561 mln usd in 2006, with 488 mln of that generated in the US.

Zelnorm has been licensed in Switzerland since the end of October 2006 for the treatment of irritable bowel syndrome and enjoyed market approval in 50 countries.