Nuedexta Approval History

• FDA approved: Yes (First approved October 29th, 2010)
• Brand name: Nuedexta
• Generic name: dextromethorphan and quinidine
• Previous name: Zenvia
• Company: Avanir Pharmaceuticals
• Treatment for: Pseudobulbar Affect

Nuedexta (dextromethorphan and quinidine) is a first-in-class dual action glutamate inhibitor indicated for the treatment of pseudobulbar affect.

FDA Approval History for Nuedexta

Date	Article
Nov  1, 2010	Avanir Pharmaceuticals Announces FDA Approval of Nuedexta
May 17, 2010	Avanir Pharmaceuticals Announces Zenvia Review Timeline Established by FDA with PDUFA Date of October 30, 2010
Apr 30, 2010	AVANIR Pharmaceuticals Submits Complete Response to FDA Approvable Letter for Zenvia in PBA
Mar 16, 2009	Zenvia Phase III PBA Trial Completes Patient Enrollment
Feb 27, 2007	AVANIR Pharmaceuticals Announces Conference Call to Provide Zenvia FDA Meeting Update
Oct 31, 2006	Avanir Receives FDA Approvable Letter for Zenvia for the Treatment of Involuntary Emotional Expression Disorder
Jun 19, 2006	FDA Informs Avanir of Revised Neurodex NDA Action Date
Apr  4, 2006	Avanir's Neurodex NDA Accepted with Priority Review for Involuntary Emotional Expression Disorder
Jan 30, 2006	Avanir Submits Expanded Neurodex New Drug Application for the Treatment of Involuntary Emotional Expression Disorder
Sep 22, 2005	Further Update on Avanir's Neurodex New Drug Application
Jun 30, 2005	Avanir Submits NDA for Neurodex
Dec 16, 2004	AVANIR Announces Submission of Rolling NDA With Priority Review for Neurodex

See also...

Nuedexta (dextromethorphan and quinidine) Consumer Information

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