FDA DELAYS APPROVAL OF AVANIR'S NEURODEX NDA
California-based Avanir Pharmaceuticals announced that the U.S. FDA has informed the company it is extending the review period of its new drug application (NDA) for Neurodex for an additional 90 days.
Neurodex (dextromethorphan/quinidine) is being developed by Avanir to treat involuntary emotional expression disorder. Avanir said the extension is needed to allow the FDA sufficient time to review the final study of its recently completed thorough QT study.
This marks the second delay for the Neurodex NDA, which was initially delayed in September, 2005, following an FDA request for additional data.