Nuedexta
Generic name: dextromethorphan and quinidine
Treatment for: Pseudobulbar Affect
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.
About AVANIR
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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Nuedexta (dextromethorphan and quinidine) FDA Approval History
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