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Nuedexta Approval History

FDA Approved: Yes (First approved October 29, 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.

Development History and FDA Approval Process for Nuedexta

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

Further information

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