NuedextaTreatment for Pseudobulbar Affect
Update: Nuedexta (dextromethorphan and quinidine) Now FDA Approved - October 29, 2010
AVANIR Pharmaceuticals Announces Conference Call to Provide Zenvia FDA Meeting Update
ALISO VIEJO, Calif., February 27, 2007 -- AVANIR Pharmaceuticals today announced that management will provide an update on its meeting with the U.S. Food and Drug Administration (FDA) on the regulatory path for Zenvia for the treatment of involuntary emotional expression disorder during a conference call to be held Wednesday, February 28, 2007 at 8:00 a.m. Eastern time / 5:00 a.m. Pacific time. The call will be webcast live through AVANIR's corporate website at www.avanir.com and will feature AVANIR's President and Chief Executive Officer Eric Brandt and Vice President of Clinical and Medical Affairs Randall Kaye, M.D. A press release summarizing the highlights of the Company's FDA meeting is expected to be released on February 28 prior to the conference call.
It is recommended that you go to AVANIR's website at least 10 minutes in advance of the webcast to download any applicable software. An archived webcast will be available for 30 days, and a phone replay will be available through March 5, 2007, by dialing 800-642-1687 (domestic) or 706-645-9291 (international) and entering the passcode 8938188.
AVANIR Pharmaceuticals is focused on developing, acquiring and commercializing novel therapeutic products for the treatment of chronic diseases. AVANIR's products and product candidates address therapeutic markets that include the central nervous system, cardiovascular disorders, inflammation and infectious diseases. AVANIR currently markets FazaClo(R), the only orally-disintegrating formulation of clozapine for the management of severely ill schizophrenic patients who fail to respond adequately to standard schizophrenic drug treatments. FazaClo is also indicated for reducing the risk of suicidal behavior in patients with schizophrenic or schizoaffective disorder. For full prescribing information and important safety information regarding FazaClo, please visit www.fazaclo.com. Zenvia, AVANIR's lead product candidate for the treatment of involuntary emotional expression disorder (IEED), is the subject of an approvable letter from the FDA and future development plans for this product candidate are under consideration. The Company does not know at this time what impact, if any, the ongoing discussions with the FDA for IEED may have on the development of Zenvia for other indications. Additionally, AVANIR has completed the patient recruitment in a Phase III clinical trial with Zenvia as a potential treatment for patients with painful diabetic neuropathy. AVANIR has active collaborations with two international pharmaceutical companies: Novartis International Pharmaceutical Ltd. for the treatment of inflammatory disease; and AstraZeneca for the treatment of cardiovascular disease. The Company's first commercialized product, abreva(R), is marketed in North America by GlaxoSmithKline Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores. Further information about AVANIR can be found at www.avanir.com.
Source: AVANIR Pharmaceuticals
Posted: February 2007
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- 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 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
- 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