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AstraZeneca Adds Avanir Reverse Cholesterol Transport Program To Vascular Pipeline

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

AstraZeneca and Avanir plan to begin development of reverse cholesterol transport enhancing compounds in late 2005 under a deal worth up to $340 mil., the firms announced July 11

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Avanir submits Neurodex NDA

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...

FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011

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