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Advisory Committee is scheduled to discuss safety and efficacy issues associated with the drug, which was temporarily withdrawn from the European market due to concerns over cardiac risks a decade ago.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.

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