Navigation Links
Avanir Pharmaceuticals Provides Update on European Regulatory Filing for NUEDEXTA
Date:7/26/2011

ALISO VIEJO, Calif., July 26, 2011 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced several positive developments regarding its anticipated European regulatory filing of NUEDEXTA® (dextromethorphan hydrobromide and quinidine sulfate) capsules for the treatment of pseudobulbar affect (PBA).  

On July 22, 2011, company officials met with the European Medicines Agency (EMA) to discuss plans for filing a marketing authorization application (MAA) for NUEDEXTA for the treatment of PBA. Based on the outcome of the meeting, the company plans to request an accelerated review process and to file for approval of NUEDEXTA using the data package which served as the basis for the U.S. Food and Drug Administration approval of NUEDEXTA. The timing of the company's MAA filing is subject to reaching an agreement with the EMA on a pediatric investigation plan (PIP) for NUEDEXTA which may occur before the end of calendar year 2011.

In addition, the company also received notification from the EMA that NUEDEXTA can be filed for approval under the agency's centralized procedure. Filing under the centralized procedure provides for a single, coordinated review that is conducted by the EMA and results in a regulatory decision which is binding on all European Union member states.  Centrally-authorized products may be marketed in all member states.

"PBA is a disabling neurologic condition affecting the lives of many people in Europe," said Professor Kevin Talbot, MBBS, DPhil, FRCP, Senior Clinical Lecturer in the Department of Clinical Neurology, and Director of the Motor Neuron Disease Care and Research Centre at University of Oxford. "As more resources are committed to understanding PBA in Europe, its prevalence and the importance of treating this disorder will be better appreciated. Meeting with the EMA is an important next step toward making a
'/>"/>

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

Page: 1 2 3 4 5

Related medicine technology :

1. Avanir Pharmaceuticals Announces Paragraph IV ANDA Filing for NUEDEXTA
2. Avanir Pharmaceuticals Reports Fiscal 2011 Second Quarter Results
3. Avanir Pharmaceuticals Announces Appointment of Elona Kogan, Esq. as Vice President of Legal Affairs
4. Avanir Pharmaceuticals to Present at the Bank of America Merrill Lynch Healthcare Conference
5. Avanir Pharmaceuticals Announces Appointment of William Sibold as Chief Commercial Officer
6. Avanir Pharmaceuticals to Present Data at the American Academy of Neurology Annual Meeting
7. Avanir Pharmaceuticals to Present at BioCentury Future Leaders in the Biotech Industry Conference
8. Avanir Pharmaceuticals to Present at Three Conferences in March
9. AVANIR Pharmaceuticals Appoints Gregory J. Flesher to Senior Vice President and Chief Business Officer
10. AVANIR Pharmaceuticals Announces Fiscal 2011 First Quarter Financial Results
11. AVANIR Pharmaceuticals Invites Investors to Fiscal 2011 First Quarter Conference Call
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/30/2014)... -- Hospital stretchers are apparatus used to transport ... or outside of medical infrastructure premises. In addition ... for several specialized functions such as hospital beds, ... The hospital stretchers market report studies the ... of hospital stretchers globally. The hospital stretchers market ...
(Date:10/27/2014)... Calif. , Oct. 27, 2014  RenovoRx, a ... blood flow and delivery of fluids to selected sites ... Board of Directors has appointed Shaun Bagai ... of the RenovoRx Board of Directors. Bagai brings more ... industry. Bagai joined RenovoRx in June 2014 ...
(Date:10/27/2014)... 27, 2014  Demonstrations by more than 50 ... featured this week in Chicago ... more than 7,000 emergency physicians are discussing the ... educational courses. These best-of-the-best innovations are ... emergency department environments, including three equipped trauma bays. ...
Breaking Medicine Technology:Hospital Stretchers Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013 - 2019 2Hospital Stretchers Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013 - 2019 3RenovoRx Board Names Shaun R. Bagai as CEO 2Emergency Medicine of the Future Demonstrated at ACEP14 2Emergency Medicine of the Future Demonstrated at ACEP14 3Emergency Medicine of the Future Demonstrated at ACEP14 4Emergency Medicine of the Future Demonstrated at ACEP14 5Emergency Medicine of the Future Demonstrated at ACEP14 6Emergency Medicine of the Future Demonstrated at ACEP14 7Emergency Medicine of the Future Demonstrated at ACEP14 8Emergency Medicine of the Future Demonstrated at ACEP14 9Emergency Medicine of the Future Demonstrated at ACEP14 10Emergency Medicine of the Future Demonstrated at ACEP14 11Emergency Medicine of the Future Demonstrated at ACEP14 12Emergency Medicine of the Future Demonstrated at ACEP14 13Emergency Medicine of the Future Demonstrated at ACEP14 14Emergency Medicine of the Future Demonstrated at ACEP14 15
... Oct. 5 Osseon Therapeutics, Inc. announced its ... North American Spine Society,s (NASS) annual meeting in ... facilitate treatment of vertebral compression fractures (VCFs) that ... fibrotic metastases.  The Osseoflex DR Steerable Bone Drill ...
... SUNNYVALE, Calif., Oct. 5 Accuray Incorporated (Nasdaq: ... of radiosurgery, announced today that the company was awarded a ... U.S. Government to be used toward further development of a ... grant will fund the development of a next generation, compact ...
Cached Medicine Technology:Osseon® Therapeutics Introduces New Osseoflex® DR Steerable Bone Drill 2Accuray Awarded $1 Million Grant by U.S. Government 2Accuray Awarded $1 Million Grant by U.S. Government 3
(Date:10/30/2014)... research group at the DFG Research Center for Regenerative ... Dresden (CRTD) demonstrated for the first time the in ... three dimensions from mouse embryonic stem cells. Correct spatial ... the dorsal/ventral axis was observed., This study has been ... Cell Reports " on 30.10.2014 ., For many years ...
(Date:10/30/2014)... NC (PRWEB) October 30, 2014 Don ... commercial, and health insurance plans for North Carolina residents, ... satellite office in Burlington’s Holly Hill Mall. The new ... with agents already helping customers through all facets of ... purchase. , Allred Insurance spokesman Scott Allred couldn’t be ...
(Date:10/30/2014)... Radio listeners who indicate use of ... impact of traditional radio commercials and have overwhelmingly endorsed ... influence a purchasing decision. , Those are some highlights ... by radio marketing company CRN International. The research is ... of respondents who indicated they have purchased or considered ...
(Date:10/30/2014)... Chicago, IL (PRWEB) October 30, 2014 Dr. ... launched a new website for his practices; OB GYN ... Chicago, IL . This website contains important information about ... covers as well as downloadable patient forms in English and ... use and the service pages on the website provide Dr. ...
(Date:10/30/2014)... Rock Hill, South Carolina (PRWEB) October 30, 2014 ... a muscle, and should be more vigorously exercised to ... Grewal. He recently authored the book ‘Dementia Express: Lose ... , The book uses counterintuitive reasoning and sometimes conflicting ... an obstacle course for the mind, a reader must ...
Breaking Medicine News(10 mins):Health News:Reconstruction of a patterned piece of spinal cord in 3-D culture 2Health News:Allred Insurance Satellite Office Grand Opening 2Health News:CRN Research On Radio Messaging Effectiveness Now Available In Four Specific Product Categories 2Health News:CRN Research On Radio Messaging Effectiveness Now Available In Four Specific Product Categories 3Health News:Dr. Joseph Furlin Launches New Website with Information about Care Services 2Health News:‘Dementia Express’ Offers Contradictory and Sometimes Reverse Thinking, All to Keep its Reader on Their Toes With an Active Mind. 2
... research scientists, students, and educators from around the world ... Association for Dental Research (IADR) holds its 87th General ... This is also the 38th Annual Meeting of the ... Annual Meeting of the Canadian Association for Dental Research ...
... relationship between coping strategies and quality of life (QOL) ... today in the online edition of Journal of ... quality of life among younger women with breast cancer ... , "It is generally assumed that coping strategies impact ...
... at American Burn Association MeetingST. PETERSBURG, Fla., March 24 ... (LSE: SN; NYSE: SNN ) will host ... at the 41st Annual Meeting of the American Burn ... present their clinical work with Smith & Nephew,s VERSAJET ...
... Hyland Software chief technology officer during a free webinar ... combats RAC challenges with document management CLEVELAND, March 24 ... three letters - RAC. The RAC, or Recovery Audit Contractor ... Medicare. And it was effective in doing just that - ...
... Cancer Center performed the world,s first successful minimally invasive ... laparoscope holder. The technology, developed in France and tested ... in a cancer setting in the United States this ... is among only a handful of institutions worldwide using ...
... "The United States is experiencing a primary care ... Jeffrey P. Harris, MD, FACP, president of the American ... Representatives Energy & Commerce Health Subcommittee. "The demand for ... the nation,s supply of primary care dwindles." , ...
Cached Medicine News:Health News:IADR holds 87th General Session and Exhibition 2Health News:Quality of life may impact coping strategies of young women with breast cancer 2Health News:Quality of life may impact coping strategies of young women with breast cancer 3Health News:Smith & Nephew Announces Symposium for Optimizing Outcomes in Burn Care 2Health News:Smith & Nephew Announces Symposium for Optimizing Outcomes in Burn Care 3Health News:Smith & Nephew Announces Symposium for Optimizing Outcomes in Burn Care 4Health News:Not Ready for RAC? Award-Winning Document Management Suite Can Help Protect Your Bottom Line 2Health News:Not Ready for RAC? Award-Winning Document Management Suite Can Help Protect Your Bottom Line 3Health News:Not Ready for RAC? Award-Winning Document Management Suite Can Help Protect Your Bottom Line 4Health News:Fox Chase performs the world’s first successful ViKY robot-assisted surgery for pancreatic tumors 2Health News:Fox Chase performs the world’s first successful ViKY robot-assisted surgery for pancreatic tumors 3Health News:US experiencing primary care shortage 'likes of which we have not seen' 2Health News:US experiencing primary care shortage 'likes of which we have not seen' 3
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
Medicine Products: