Navigation Links
Avanir Pharmaceuticals Submits European Marketing Authorization Application for NUEDEXTA
Date:10/31/2011

ALISO VIEJO, Calif., Oct. 31, 2011 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) announced today that it has submitted an application to the European Medicines Agency (EMA) seeking marketing authorization for NUEDEXTA® (dextromethorphan HBr and quinidine sulfate) for the treatment of pseudobulbar affect (PBA).

NUEDEXTA was approved by the U.S. Food and Drug Administration in October 2010 for the treatment of PBA, a neurologic condition which is characterized by frequent outbursts of involuntary crying or laughing.

The marketing authorization application (MAA) is based on comprehensive clinical data from Avanir's phase 3 studies of NUEDEXTA in patients with PBA, plus data from the company's longer-term safety studies. The MAA filing triggers the initiation of EMA's validation process which is expected to be completed in November.  Once the MAA has passed validation, the scientific assessment and opinion review period will take a minimum of 210 days.

"The regulatory submission announced today represents another significant accomplishment for Avanir," said Joao Siffert, MD, senior vice president research and development at Avanir. "PBA affects millions of people across the globe and imposes a significant health burden on those suffering from this condition. The filing of this application with the EMA is an important step toward making NUEDEXTA available for PBA patients in Europe. The European medical community is looking forward to the day when they can offer the only therapeutic specifically approved for treating patients with PBA."

Financial Update

Based on preliminary results for the fourth fiscal quarter ended September 30, 2011, Avanir estimates gross revenue for NUEDEXTA of $4.3 million. This represents an approximate increase of 95% over the gross revenue for NUEDEXTA of $2.2 million in the third fiscal q
'/>"/>

SOURCE Avanir Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. Avanir Pharmaceuticals to Present Data at the 2011 American Congress of Rehabilitation Medicine/American Society for Neurorehabilitation Medicine Annual Conference
2. Avanir Pharmaceuticals to Participate in Two Investor Conferences
3. Avanir Pharmaceuticals to Present at Stifel Nicolaus Healthcare Conference
4. Avanir Pharmaceuticals Files Lawsuits Against Par and Actavis for Infringement of NUEDEXTA Patents
5. Avanir Pharmaceuticals Reports Fiscal 2011 Third Quarter Financial Results
6. Avanir Pharmaceuticals Announces Appointment of Dr. Joao Siffert as Senior Vice President Research and Development
7. Avanir Pharmaceuticals to Present at Two Investor Conferences in August
8. Avanir Pharmaceuticals Provides Update on European Regulatory Filing for NUEDEXTA
9. Avanir Pharmaceuticals Announces Paragraph IV ANDA Filing for NUEDEXTA
10. Avanir Pharmaceuticals Reports Fiscal 2011 Second Quarter Results
11. Avanir Pharmaceuticals Announces Appointment of Elona Kogan, Esq. as Vice President of Legal Affairs
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/21/2014)...  An International Trade Commission (ITC) ruling issued Friday ... device, Taiwanese device manufacturer APEX continues to infringe ResMed ... ) is the innovation leader and pioneer in designing ... "Our research and development teams are ... of comfort, performance and efficacy," said David Pendarvis ...
(Date:7/21/2014)... Apex Medical Corporation (Apex, TWSE: 4106), a leading player ... announces that the United States International Trade Commission (USITC) ... newly designed XT series continuous positive airway pressure (CPAP) ... the patent claims asserted by ResMed, one of Apex,s ... an upgraded iCH water tank to the market in ...
(Date:7/18/2014)... 2014 Hanger, Inc. (NYSE: HGR ) ... operations for the quarter ended June 30, 2014, on Tuesday, ... to discuss these results is scheduled to begin at 9:00 ... participate should call 1-877-662-6095. A replay will be available until ... ID # 44683027. About Hanger, Inc. – Built ...
Breaking Medicine Technology:ITC Rules Redesigned APEX Humidifier Still Infringes ResMed Patents 2Apex Medical's Respiratory Therapy Product Receives Affirmation from USITC 2
... an international generic pharmaceuticals company, today announced that ... Food & Drug Administration to market Zolpidem Tartrate ... the product has commenced.   Actavis ... Extended-Release Tablets 6.25 mg strength in October 2010 with ...
... 6, 2011 Pharmacyclics, Inc. (Nasdaq: PCYC ... the Phase IB/II study of the Btk inhibitor, PCI-32765, ... (CLL/SLL) at the 2011 American Society of Clinical Oncology ... development program update for the Btk Inhibitor, PCI-32765.  The ...
Cached Medicine Technology:Actavis Receives FDA Approval of Zolpidem Tartrate Extended-Release Tablets USP, 12.5 mg CIV in the U.S. 2Pharmacyclics Reports Recent Developments From Clinical Studies of its Btk Inhibitor PCI-32765 2Pharmacyclics Reports Recent Developments From Clinical Studies of its Btk Inhibitor PCI-32765 3Pharmacyclics Reports Recent Developments From Clinical Studies of its Btk Inhibitor PCI-32765 4Pharmacyclics Reports Recent Developments From Clinical Studies of its Btk Inhibitor PCI-32765 5Pharmacyclics Reports Recent Developments From Clinical Studies of its Btk Inhibitor PCI-32765 6Pharmacyclics Reports Recent Developments From Clinical Studies of its Btk Inhibitor PCI-32765 7Pharmacyclics Reports Recent Developments From Clinical Studies of its Btk Inhibitor PCI-32765 8Pharmacyclics Reports Recent Developments From Clinical Studies of its Btk Inhibitor PCI-32765 9
(Date:7/21/2014)... 2014 iFitDress.com, a famous company of ... announced its exclusive collection of 2014 glitter evening ... for its brand new gowns. , iFitDress.com is one ... market. Its sales boomed in the recent years, not ... also because of the amicable services offered on its ...
(Date:7/21/2014)... MA (PRWEB) July 21, 2014 What ... extramarital affair have in common? You can find them ... Heart! The novel's main character, Miranda, lives on Martha’s ... meets Clay, a wealthy New Yorker, and becomes entangled ... of the Heart challenges readers to think about what ...
(Date:7/21/2014)... Executives from Advice Media, the ... healthcare practices, will participate in this week’s International ... showcasing their state-of-the-art capabilities and successes in implementing ... the United States as the importance for doctors ... Advice Media’s presence at IACA comes on the ...
(Date:7/21/2014)... Press-NORC Center for Public Affairs Research has released the ... about what it means to be a quality health ... by the Robert Wood Johnson Foundation, sheds new light ... health care and doctors, as well as the information ... The survey produces new and actionable data during a ...
(Date:7/21/2014)... 21, 2014 (HealthDay News) -- Good parenting and ... children from low-income families, a new study suggests. ... children, and can lead to a number of ... health problems in both childhood and adulthood involve ... diabetes, heart disease, allergies and some cancers," study ...
Breaking Medicine News(10 mins):Health News:iFitDress.com: 2014 Glitter Evening Dresses For Worldwide Clients 2Health News:Thea Marsh Releases Debut Novel that Celebrates and Reaches out to Women Everywhere 2Health News:Advice Media to Attend the International Association of Comprehensive Aesthetics Conference (IACA) Targeting the Dental Profession 2Health News:National survey from AP-NORC examines perceptions of health care provider quality 2Health News:Life Skills, Parenting Classes May Cut Inflammation in Poor Kids 2
... unclear why it’s so, scientists at Johns Hopkins have linked ... tough//, protective casing that houses insects and worms to the ... ,A team of Hopkins sinus experts has found that the ... to 250 times more active in people with severe sinus ...
... say that there is nothing that matches gambling. Not even ... addict//. ,There has been an upsurge of gambling ... with gambling problems. According to some experts, this has led ... ,"It's related to other addictions, like alcoholism and tobacco addiction. ...
... may no longer be included in the specialist category, if ... ,A few radiologists who have had the opportunity ... them as part of the team. But the rest are ... physicians are unable to seek employment in breast clinics. And ...
... common man has seen a rapid increase in healthcare charges ... been affected not only by the rising cost of living// ... money-spinning business. ,The government in 2003 revised the ... had the benefit of ‘free’ hospital visits. In fact, they ...
... 10, sent a warning against dengue fever in the midst ... capital//. ,From this year’s January 1 to ... been reported, said the department. ,In order ... collaboration with the local officials of the affected areas, according ...
... and Drug Administration has charged the American Red Cross yet ... to the stipulation of safe blood collection techniques.// The Red ... the nation's requirement of blood, has been under the vigilance ... make the blood safe by enhancing the quality control system., ...
Cached Medicine News:Health News:Immune Response Linked to “Ghost” Parasites and Severely Congested Sinus 2Health News:Immune Response Linked to “Ghost” Parasites and Severely Congested Sinus 3Health News:Immune Response Linked to “Ghost” Parasites and Severely Congested Sinus 4Health News:Compulsive Gambling – a psychiatric disorde 2Health News:Escalating Healthcare charges in UAE 2Health News:Escalating Healthcare charges in UAE 3Health News:‘Search and Destroy’ operation against dengue mosquitoes in Philippin 2
Determination of the Thrombin Time by STA Analyzers. Freeze-dried human thrombin (1.5NIH units/mL) with calcium....
Quantitative determination of Fibrinogen (Clauss Method). Freeze-dried human thrombin (~100NIH units/mL) with heparin inhibitor and calcium....
Determination of Prothrombin Time (PT) by STA Analyzers (ISI~1.3).Freeze-dried rabbit brain thromboplastin with heparin inhibitor....
Determination of Prothrombin Time (PT)by STA Analyzers (ISI~1.8).Freeze-dried rabbit brain thromboplastin with heparin inhibitor....
Medicine Products: