Nuedexta
Generic name: dextromethorphan and quinidine
Treatment for: Pseudobulbar Affect
Avanir Submits Expanded Neurodex New Drug Application for the Treatment of Involuntary Emotional Expression Disorder
SAN DIEGO, January 30, 2006 - Avanir Pharmaceuticals (AMEX:AVN.R) announced today that on Friday, January 27, 2006, it completed the submission of its new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for Neurodex, seeking marketing approval of the drug candidate for the treatment of involuntary emotional expression disorder, also known as pseudobulbar affect or emotional lability. The application was resubmitted to the FDA to provide an expansion of certain summary analyses which better support the electronic common technical document (e-CTD) format.
The application is based on clinical data supporting that Neurodex, a combination of dextromethorphan and low dose quinidine, is safe and effective in reducing the frequency and severity of sudden and uncontrollable crying and/or laughing episodes that occur as a consequence of neurological disease or injury. Avanir has formally requested priority review status from the FDA for this application. If the FDA grants Avanir's priority review request, the date for the agency to take action on the application will be six months from the filing date. If standard review status is granted, a review time of ten months will apply to the application.
"We are very pleased to announce this important submission. While the FDA's request was limited to reorganization and expanded discussions of existing data within the electronic document, we took the time to include additional safety data rather than providing it as a separate supplemental filing as originally planned. The additional safety data are consistent with the data previously submitted," said Eric K. Brandt, President and Chief Executive Officer of Avanir. "We feel the application is strengthened, and look forward to hearing from the FDA over the next sixty days regarding the fileability status and the review designation granted for our application."
For more information, please visit Avanir Pharmaceuticals
Posted: January 2006
Related articles
- Avanir Pharmaceuticals Announces FDA Approval of Nuedexta - November 1, 2010
- Avanir Pharmaceuticals Announces Zenvia Review Timeline Established by FDA with PDUFA Date of October 30, 2010 - May 17, 2010
- 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
- Avanir Receives FDA Approvable Letter for Zenvia for the Treatment of Involuntary Emotional Expression Disorder - October 31, 2006
- 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
- 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
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
