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Avanir submits Neurodex NDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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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