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:4/18/2014)... San Diego, Calif. (April 18, 2014) ― A new ... analyzing weekly patterns in health-related Google searches reveals ... public health strategies. , Investigators from San ... University, and the Monday Campaigns, analyzed "healthy" Google searches ... health-related, e.g., "healthy diet") originating in the U.S. from ...
(Date:4/17/2014)... genetic variant specifically associated with the risk of ... per cent of all breast cancer cases. , ... sub-type, called invasive lobular carcinoma, gives researchers important ... kind of breast cancer, which can be missed ... in the journal PloS Genetics , was ...
(Date:4/17/2014)... of California, San Diego School of Medicine report that ... a recent major loss are more likely to be ... study is published in this month,s issue of the ... compassionate behaviors are associated with better health and well-being ... ways to improve the outcomes of individuals whose deficits ...
(Date:4/17/2014)... 2014U.S. military personnel who served in Iraq and ... brain injury (TBI) were compared to military personnel ... reasons. Differences in measures of overall disability, cognitive ... injury are reported in an article in ... Mary Ann Liebert, Inc., publishers. The article is ...
(Date:4/17/2014)... By discovering a new mechanism that allows blood to ... UC Irvine and the Salk Institute have opened the ... stroke-induced brain damage. , A complex and devastating neurological ... primary reason for disability in the U.S. The blood-brain ... blood-borne material into the brain, causing the permanent deficits ...
Breaking Medicine News(10 mins):Health News:New research shows people are thinking about their health early in the week 2Health News:First genetic link discovered to difficult-to-diagnose breast cancer sub-type 2Health News:First genetic link discovered to difficult-to-diagnose breast cancer sub-type 3Health News:The ilk of human kindness 2Health News:Long-term effects of battle-related 'blast plus impact' concussive TBI in US military 2Health News:Study IDs new cause of brain bleeding immediately after stroke 2
... (HealthDay News) -- Voter registration cards may offer more insight ... or appearance, new research suggests. Most people marry those ... study from Rice University and the University of Nebraska-Lincoln. ... Politics , examined the physical, personality and behavioral traits of ...
... students to surgeons, anyone who has pulled an all-nighter knows ... trouble focusing, a fuzzy memory and other cognitive impairments. ... brain and the neurochemical basis for sleep deprivation,s effects on ... Penn,s School of Arts and Sciences and director of the ...
... , TUESDAY, May 17 (HealthDay News) -- Concern about vaccine ... in the United States are reluctant to have their asthmatic ... study also found that parents who don,t vaccinate their asthmatic ... trigger for their child,s asthma. Flu vaccination is recommended ...
... findings show that treatment with a specific alpha blocker ... men with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). ... the muscles in the bladder neck and prostate. The ... the EU and Japan to treat painful symptoms of ...
... 17 (HealthDay News) -- A gene variation that causes faulty ... hormone progesterone and may be a reason why some women ... team looked at more than 200 infertile women who were ... the variation of the scavenger receptor class B type 1 ...
... research by a University of Illinois law and labor ... and owners, courts have consistently failed to maintain a ... players in the three major sports football, baseball ... collective bargaining and antitrust litigation to eliminate owner-imposed constraints ...
Cached Medicine News:Health News:Politics May Trump Looks, Personality in Matters of the Heart 2Health News:Penn researchers identify the roots of memory impairment resulting from sleep deprivation 2Health News:Penn researchers identify the roots of memory impairment resulting from sleep deprivation 3Health News:Parent's Fears Deprive Some Asthmatics of Flu Shot: Study 2Health News:Experimental treatment offers relief from painful prostate condition 2Health News:Gene Variation May Explain Some Female Infertility Cases 2Health News:Pro athletes ought to bargain outside federal court, legal scholar says 2Health News:Pro athletes ought to bargain outside federal court, legal scholar says 3Health News:Pro athletes ought to bargain outside federal court, legal scholar says 4
(Date:1/15/2014)... 15, 2014 The Cadence Fitness & Health Center ... the Medical Fitness Association, a non-profit organization assisting medically ... potential. The Cadence Fitness & Health Center is the ... second in the Chicagoland area. "The certification ...
(Date:1/15/2014)... YORK , Jan. 15, 2014 ... report is available in its catalogue: ... Forecast – Worldwide Analysis ... Market Analysis Insulin ...
(Date:1/15/2014)... LAVAL, Quebec , Jan. 15, 2014  Valeant Pharmaceuticals ... VRX) announced that the applicable waiting period under the ... to the previously announced tender offer by its indirect ... the outstanding shares of common stock of Solta Medical, ...
Breaking Medicine Technology:Cadence Fitness & Health Center Certified as Medical Fitness Facility 2Cadence Fitness & Health Center Certified as Medical Fitness Facility 3Insulin Pump Market & Forecast - Worldwide Analysis 2Insulin Pump Market & Forecast - Worldwide Analysis 3Insulin Pump Market & Forecast - Worldwide Analysis 4Insulin Pump Market & Forecast - Worldwide Analysis 5Insulin Pump Market & Forecast - Worldwide Analysis 6Insulin Pump Market & Forecast - Worldwide Analysis 7Insulin Pump Market & Forecast - Worldwide Analysis 8Insulin Pump Market & Forecast - Worldwide Analysis 9Insulin Pump Market & Forecast - Worldwide Analysis 10Insulin Pump Market & Forecast - Worldwide Analysis 11Insulin Pump Market & Forecast - Worldwide Analysis 12Insulin Pump Market & Forecast - Worldwide Analysis 13Insulin Pump Market & Forecast - Worldwide Analysis 14Insulin Pump Market & Forecast - Worldwide Analysis 15Insulin Pump Market & Forecast - Worldwide Analysis 16Insulin Pump Market & Forecast - Worldwide Analysis 17Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 2Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 3
... 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 ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... 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: