FDA Eyes Heart Risks Of Proposed Lundbeck Drug

Law360, New York (April 3, 2009, 12:00 AM EDT) -- Officials at the U.S. Food and Drug Administration have expressed concern about a risk of cardiac arrhythmia and death associated with Danish drugmaker H. Lundbeck A/S's proposed schizophrenia drug Serdolect.

When it meets on Tuesday, the FDA's Psychopharmacologic Drugs Advisory Committee is scheduled to discuss safety and efficacy issues associated with the drug, which was temporarily withdrawn from the European market due to concerns over cardiac risks a decade ago.

Lundbeck filed a new drug application for Serdolect in the U.S. in September 2008.

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

UK Financial Services

UK Financial Services

Read Our Latest UK Financial Services Coverage

Financial Services Law360 UK provides breaking news and analysis on the financial sector. Coverage includes UK and European Union policy, enforcement, and litigation involving banks, asset management firms, and other financial services organizations.