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:12/15/2014)... -- Colorado and Washington State are not ... Oregon , Alaska , ... the November 2014 elections. Photo - ... The benefits of legalizing cannabis are manifold. There ... increased tax revenue for state and local governments, in addition ...
(Date:12/15/2014)... , Dec. 15, 2014   DaVita HealthCare ... of the nation,s largest and most innovative health ... business units, DaVita Clinical Research  (DCR) and  HealthCare ... further expand its extensive clinical research and data ... disease (CKD) and end-stage renal disease (ESRD), as ...
(Date:12/13/2014)... Research and Markets ( http://www.researchandmarkets.com/research/2r6bmg/drug_injection ... "Drug Injection Devices to 2020" report to ... As new drugs become available ... health conditions, drug developers have increasingly pursued packaging ... and increase the efficiency and reliability with which ...
Breaking Medicine Technology:CannaInsider.com Estimates 200,000 New Jobs in the Cannabis Industry by 2015 2DaVita Clinical Research and HealthCare Partners Clinical Research to Merge and Expand Clinical Trials and Data Analytics Capabilities 2DaVita Clinical Research and HealthCare Partners Clinical Research to Merge and Expand Clinical Trials and Data Analytics Capabilities 3DaVita Clinical Research and HealthCare Partners Clinical Research to Merge and Expand Clinical Trials and Data Analytics Capabilities 4Drug Injection Devices to 2020 2Drug Injection Devices to 2020 3Drug Injection Devices to 2020 4
(Date:12/17/2014)... (PRWEB) December 17, 2014 Now in ... celebrate the best of the best in senior living ... is only given to communities and agencies that have ... SeniorAdvisor.com site. Of the nearly 100,000 providers currently listed ... Winners of the SeniorAdvisor.com Best of 2015 Awards are ...
(Date:12/17/2014)... By Alan Mozes ... -- In the world of infectious diseases, one worrisome phenomenon ... into people. The process -- known as zoonosis -- ... they look for signs that an animal-borne disease might make ... on just such a development -- and the culprits in ...
(Date:12/17/2014)... Greater participation in music classes may benefit children,s language ... in the nonprofit Harmony Project, which provides music education ... Over two years, children who actively participated in the ... speech and reading, compared to those with lower levels ... in music classes occurred in the same areas of ...
(Date:12/17/2014)... HealthDay Reporter , TUESDAY, Dec. 16, ... America, and work commitment is a big reason why, new ... said Dr. Mathias Basner, an assistant professor of sleep and ... of Medicine. A time-use survey of nearly 125,000 Americans, ... main activity exchanged for sleep. Short sleepers -- those who ...
(Date:12/15/2014)... NV (PRWEB) December 15, 2014 Veretekk.com, ... company, JM Ocean Avenue. JM Ocean Avenue has ... the Veretekk online automated marketing system. JM Ocean ... June 2014 merger of Ocean Avenue and JM International, ... than $2 Billion per year company. , “After nearly ...
Breaking Medicine News(10 mins):Health News:The Inn at Willow Falls - Crest Hill, IL Wins 2015 Best of Assisted Living Award from SeniorAdvisor.com 2Health News:The Inn at Willow Falls - Crest Hill, IL Wins 2015 Best of Assisted Living Award from SeniorAdvisor.com 3Health News:Guinea Pigs Can Be Source of Serious Strep Infection 2Health News:Guinea Pigs Can Be Source of Serious Strep Infection 3Health News:Music Classes Boost Language Skills, Study Says 2Health News:Work Steals Valuable Sleep Time, Study Finds 2Health News:Work Steals Valuable Sleep Time, Study Finds 3Health News:JM Ocean Avenue secures the strategic advantages of Veretekk 2Health News:JM Ocean Avenue secures the strategic advantages of Veretekk 3Health News:JM Ocean Avenue secures the strategic advantages of Veretekk 4
... highest levels at almost twice the risk, regardless of ... -- A new study has found a strong association ... leads to a four-to-five times increased risk of heart ... levels of insulin resistance (often a precursor to diabetes) ...
... researchers at the University of Pennsylvania School of Medicine ... motor areas of the brains of patients with amyotropic ... same group has shown that TDP-43 accumulates throughout the ... appreciated and treatments need to take into account more ...
... COLUMBIA, Mo. Many women experience menopausal changes in ... the changes they don,t notice can be more dangerous. ... Missouri have discovered significant changes in the brain,s vascular ... predict that currently used estrogen-based hormone therapies may complicate ...
... Mike,Leavitt today declared a public health emergency in ... gives HHS, Centers for Medicare &,Medicaid Services, (CMS) ... in meeting emergency health needs., "The flooding ... individual and,to their communities," Secretary Leavitt said. "This ...
... Staff, and 7 other HFI usability, experts speak ... research topics including, ,Who are We ... YORK, June 16 Human Factors International (HFI),the ... "platinum",sponsorship of the 2008 Usability Professionals, Association International,Conference. ...
... of therapeutic agents that interferes with the ability of ... The results of the new study will be presented ... Meeting in San Francisco. , The cell-based study ... compounds are likely to be effective against breast cancers ...
Cached Medicine News:Health News:Insulin Resistance Tied to Peripheral Artery Disease 2Health News:Lou Gehrig's protein found throughout brain, suggesting effects beyond motor neurons 2Health News:Complex changes in the brain's vascular system occur after menopause 2Health News:HHS Takes Action to Help Medicare Beneficiaries and Providers in Iowa and Indiana 2Health News:HHS Takes Action to Help Medicare Beneficiaries and Providers in Iowa and Indiana 3Health News:Human Factors International Sponsors Usability Professionals' Association (UPA) 2008 International Conference 2Health News:Human Factors International Sponsors Usability Professionals' Association (UPA) 2008 International Conference 3Health News:Future hope for patients with breast cancers resistant to tamoxifen 2
Medtronic Ophthalmics offers a comprehensive selection of corneal trephine,blades and handles. Handcrafted, sharp, uniform blade edges promote a,symetrical and vertical cut of all corneal layers....
Medtronic Ophthalmics offers a comprehensive selection of corneal trephine,blades and handles. Handcrafted, sharp, uniform blade edges promote a,symetrical and vertical cut of all corneal layers....
Medtronic Ophthalmics offers a comprehensive selection of corneal trephine,blades and handles. Handcrafted, sharp, uniform blade edges promote a,symetrical and vertical cut of all corneal layers....
Each handle is designed to fit a specific trephine size....
Medicine Products: