AVANIR

U.S. Food and Drug Administration informs AVANIR of revised Neurodex NDA action date

Published in Health Insurance Week, July 23rd, 2006

AVANIR Pharmaceuticals (AVNR) announced that it was advised in a teleconference with the U.S. Food and Drug Administration (FDA), that the Agency will extend the review period by 90 days for the Neurodex new drug application (NDA) for Involuntary Emotional Expression Disorder (IEED).

The new PDUFA date will be October 30, 2006. The additional time is needed to allow the FDA sufficient time to review the final study report of the recently completed thorough QT study.

"While we are disappointed that there will be a delay in hearing about the status of the Neurodex NDA, we believe the QT data provides added support to the safety profile of the drug,"...

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Source: Health Insurance Week (2006-07-23)

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