Nuedexta FDA 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 timeline for Nuedexta
| Date | Article |
|---|
| Nov 1, 2010 | Approval 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 |
Further information
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