Navigation Links
FDA Advisory Committee Recommendation on SEROQUEL XR Supplemental New Drug Applications
Date:4/20/2009

WILMINGTON, Del., April 8 /PRNewswire-FirstCall/ -- Today, the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) conducted a review of the safety and efficacy of supplemental new drug applications (sNDA) for SEROQUEL XR (quetiapine fumarate) extended-release tablets proposed for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD).

The Advisory Committee concluded:

  • SEROQUEL XR was shown to be effective in MDD as both monotherapy and adjunctive therapy, and shown to be effective in GAD as monotherapy.
  • SEROQUEL XR was shown to be acceptably safe as an adjunctive treatment for MDD.
  • SEROQUEL XR was not shown to be acceptably safe as a monotherapy for broad treatment for MDD.
  • The committee was undecided as to whether SEROQUEL XR was shown to be acceptably safe in certain instances as a monotherapy treatment for MDD.
  • SEROQUEL XR was not shown to be acceptably safe as a monotherapy for the treatment of GAD.

Howard Hutchinson, M.D., Chief Medical Officer of AstraZeneca, said: "We are pleased that the committee found SEROQUEL XR to be effective and acceptably safe for use as adjunctive therapy for the treatment of MDD. Although the committee recognized the effectiveness of SEROQUEL XR as monotherapy for MDD and GAD, they had concerns around the long-term safety profile in these new populations. We look forward to having further discussions with the FDA regarding both sNDAs."

The FDA frequently convenes advisory committee meetings to obtain independent expert guidance and recommendations on clinical matters. While the FDA is not required to follow this guidance, the agency usually takes the advice into consideration when rendering its final decisions on pending applications and other public health matters.


'/>"/>
SOURCE AstraZeneca
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine news :

1. Obama Nominates Former Advisory Board Company Executive
2. Leading Independent Proxy Advisory Firm Supports Specialty Underwriters Alliance, Inc. in Its Proxy Contest Against Hallmark Financial Services, Inc.
3. 2010 Dietary Guidelines Advisory Committee Meeting to Be Webcast April 29th and 30th
4. Former Executive at Genzyme Corp. and Osiris Therapeutics, Inc. to Head Business Advisory Board at Rx for Africa, Inc.
5. Universal Capital Management Reports Top Delaware Surgeon to Join Advisory Board
6. FDA Advisory Committee Recommendation on SEROQUEL XR Supplemental New Drug Applications
7. Gene Network Sciences Names Departing Merck Head of Genetics Eric Schadt as Co-Chair of Scientific Advisory Board
8. N30 Pharma Forms Scientific Advisory Board
9. FDA Advisory Committee Documents for SEROQUEL XR Available on AstraZeneca Web Site
10. Advanced Life Sciences Announces Results of Shareholder Meeting and Provides Additional Information on Upcoming Advisory Committee Meeting
11. Pennsylvania Patient Safety Authority Releases March Advisory
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/30/2014)... (PRWEB) September 30, 2014 TrailMyx.com ... its October Flavor of the Month: raw pumpkin seeds. ... seed of squash”)—are rich in protein, and valued by ... and multiple types of vitamin E. They are prized ... function and proper bowel function. , Of course, pumpkin ...
(Date:9/30/2014)... Pivotal 5, LLC, a proven leader in ... – The Healthy Way of Life CompanySM (NYSE: LTM) ... Training . KettleWorX Group Training is a three-dimensional training ... of all fitness levels a means to enter into ... rollout to Life Time Athletic destinations will be KettleWorX’s ...
(Date:9/30/2014)... University of Michigan have described a new approach to ... the time needed for more traditional methods. , ... that is undergoing further investigation as a potential treatment ... , In research published online in the Proceedings ... the lab of Stephen Weiss at the U-M Life ...
(Date:9/30/2014)... 30, 2014 Visiting Nurse Association (VNA) ... pleased to announce that Steven Landers, MD, MPH, president ... “40 Under 40” award on Monday evening. The ... young businessmen and women who have been making headlines ... business growth, professional excellence and to the community. , ...
(Date:9/30/2014)... September 30, 2014 During this ... natural approaches to health including achieving hormonal balance, ... deficiencies and detoxification. , The ... , Date: October 6-9, 2014, Location: Online Event, ... http://www2.hotzehwc.com/naturalhealthsummitregistration , Monday, October 6th, Steven ...
Breaking Medicine News(10 mins):Health News:TrailMyx.com Features October Flavor of the Month 2Health News:Pivotal 5 Announces Life Time Fitness As National Destination For KettleWorX Kettlebell Training 2Health News:Pivotal 5 Announces Life Time Fitness As National Destination For KettleWorX Kettlebell Training 3Health News:New discovery approach accelerates identification of potential cancer treatments 2Health News:Visiting Nurse Association Health Group’s Dr. Steven Landers Honored with NJ BIZ “40 Under 40” Award 2Health News:Visiting Nurse Association Health Group’s Dr. Steven Landers Honored with NJ BIZ “40 Under 40” Award 3Health News:Hotze Health & Wellness Center Announces First Natural Health Summit 2
... , CHERRY HILL, N.J., Aug. 25 Nuvilex, ... a shareholder newsletter on September 1, 2009. Additionally, regional shareholder meetings ... on September 17th, and Los Angeles on September 18th. Regional shareholder ... 7, 2009. , , "We are very aware ...
... , DES MOINES, Iowa, Aug. 25 The Graham ... Medical Plaza II, a three-story, 70,000 square-foot medical office building serving ... building located on the campus of Carondelet St. Mary,s Hospital, a ... The offices currently include the Carondelet Medical Group, a large family ...
... WILMINGTON, Del., Aug. 25 While many pharmaceutical ... and Mitigation Strategy (REMS) programs for many new and old ... program evaluations beginning just 1-1/2 years after each REMS is ... has been issued by risk management expert Jeffrey Fetterman, CEO ...
... Nottingham and Health Protection Agency East Midlands are carrying out ... as part of the government,s response to the pandemic. ... contagious for and advise on a ,safe distance, from the ... Nguyen Van Tam of the University of Nottingham,s School of ...
... TIPP CITY, Ohio, Aug. 25 One month ago, ... began his quest to bicycle through all 48 states in the continental U.S. ... hometown of Tipp City, Ohio, Nagle now has passed well beyond the halfway ... , , In addition to eyeing a Guinness World ...
... WASHINGTON, Aug. ... the United States $4.5 million to resolve allegations that it violated the ... , This ... financial relationships with five physicians that violated the Stark Law. The ...
Cached Medicine News:Health News:Nuvilex to Issue Positive Shareholder Newsletter 2Health News:Nuvilex to Issue Positive Shareholder Newsletter 3Health News:Nuvilex to Issue Positive Shareholder Newsletter 4Health News:Nuvilex to Issue Positive Shareholder Newsletter 5Health News:Nottingham scientists commissioned for urgent swine flu research 2Health News:College Student's '48 States in 48 Days' Bike Ride Moves Well Beyond the Halfway Point 2Health News:Covenant Medical Center to Pay U.S. $4.5 Million to Resolve False Claims Act Allegations 2
(Date:9/29/2014)... -- Repeated exposure to broad-spectrum antibiotics in the first two ... say researchers from The Children,s Hospital of ... data from electronic health records from the extensive CHOP ... children with four or more exposures to broad spectrum ... at risk for obesity. The study, published online September ...
(Date:9/29/2014)... Pharmacists have an important role in ... good clinical trials practices. The Hematology/Oncology Pharmacy Association ... Practice Standards, the first of its kind that ... pharmacists and institutions that conduct clinical trials. The ... the critical role of the pharmacist in the ...
(Date:9/29/2014)... NEW YORK , Sept. 29, 2014 ... Summary GlobalData,s new report, "EU5 ... market data on the EU5 Capsule Endoscopy Systems market. ... volume (in units) and average prices (in US dollars) ... Recorders and Capsule Endoscopy Workstations. The report ...
Breaking Medicine Technology:Antibiotic Use by Age 2 Associated with Obesity Risk 2Antibiotic Use by Age 2 Associated with Obesity Risk 3HOPA Introduces First Investigational Drug Service Best Practice Standards For Institutions And Infusion Clinics 2HOPA Introduces First Investigational Drug Service Best Practice Standards For Institutions And Infusion Clinics 3EU5 Capsule Endoscopy Systems Market Outlook to 2020 2EU5 Capsule Endoscopy Systems Market Outlook to 2020 3
... and Company (NYSE: LLY ) announced the ... Committee voted today to recommend non-approval of liprotamase, a ... review for the treatment of exocrine pancreatic insufficiency (EPI). ... questions about the degree of efficacy of liprotamase and ...
... gloStream, maker of gloEMR and gloPM – the only ... software with Microsoft Office built right in – today announced ... the gloEMR product line. Like its predecessor versions, gloEMR 6.0 ... platform, SQL Server and Microsoft Office so users have access ...
Cached Medicine Technology:Statement From Lilly on FDA Advisory Committee Recommendation Regarding Liprotamase New Drug Application for Treatment of Exocrine Pancreatic Insufficiency 2gloStream Announces Release of Microsoft-Based, Meaningful Use Certified gloEMR 6.0 2gloStream Announces Release of Microsoft-Based, Meaningful Use Certified gloEMR 6.0 3
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... 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 ...
Medicine Products: