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Avanir Neurodex NDA Delayed By FDA Request For Additional Analyses

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Avanir will meet with FDA "within the next few weeks" to discuss delays in its NDA for Neurodex for treatment of pseudobulbar affect, the firm says

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Avanir is requesting a priority review for use of its anti-excitatory therapy Neurodex (dextromethorphan/quinidine) in the treatment of pseudobulbar affect (PBA). The firm completed a rolling submission of the NDA for the neurological disorder June 29. A priority review designation would make approval possible before year end. Avanir previously estimated the U.S. PBA market at $500 mil.; the firm also indicated it planned to have 70 reps in place for launch (1Pharmaceutical Approvals Monthly September 2004, p. 13). PBA is a symptom complex secondary to multiple neurological conditions including Alzheimer's, Parkinson's, multiple sclerosis and stroke...

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