Nuedexta
Generic name: dextromethorphan and quinidine
Treatment for: Pseudobulbar Affect
Avanir Receives FDA Approvable Letter for Zenvia for the Treatment of Involuntary Emotional Expression Disorder
SAN DIEGO, October 31, 2006 - Avanir Pharmaceuticals announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for Zenvia (formerly referred to as Neurodex) for the treatment of involuntary emotional expression disorder ("IEED"). The Company submitted a new drug application ("NDA") in January 2006, seeking to market Zenvia for the treatment of IEED in patients with neurologic diseases and brain injuries. The communication from the FDA indicates that Avanir's application is approvable, subject to the FDA and Avanir reaching agreement on what additional safety and efficacy data will be required. In accordance with FDA procedures, the Company anticipates scheduling a meeting with the agency to discuss the approvable letter. Until the Company is able to meet with the agency, it can not comment on the specifics of the approvable requirements. Additionally, the Company cannot be certain that once it has met with the FDA, that it will choose to continue with the development of Zenvia as previously planned.
"We will be working closely with the agency to determine the next steps required for the drug to receive marketing approval," said Eric K. Brandt, President and Chief Executive Officer of Avanir. "We believe Zenvia can significantly improve the lives of patients, their families and their caregivers by reducing the emotional and social toll taken by IEED."
For more information, please visit Avanir Pharmaceuticals
Posted: October 2006
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- AVANIR Pharmaceuticals Submits Complete Response to FDA Approvable Letter for Zenvia in PBA - April 30, 2010
- Zenvia Phase III PBA Trial Completes Patient Enrollment - March 16, 2009
- AVANIR Pharmaceuticals Announces Conference Call to Provide Zenvia FDA Meeting Update - February 27, 2007
- FDA Informs Avanir of Revised Neurodex NDA Action Date - June 19, 2006
- Avanir's Neurodex NDA Accepted with Priority Review for Involuntary Emotional Expression Disorder - April 4, 2006
- Avanir Submits Expanded Neurodex New Drug Application for the Treatment of Involuntary Emotional Expression Disorder - January 30, 2006
- Further Update on Avanir's Neurodex New Drug Application - September 22, 2005
- Avanir Submits NDA for Neurodex - June 30, 2005
- AVANIR Announces Submission of Rolling NDA With Priority Review for Neurodex - December 16, 2004
Nuedexta (dextromethorphan and quinidine) FDA Approval History
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