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:1/22/2015)... 22, 2015 Gabe’s Chemo Duck Program is pleased ... first app ever created for kids with cancer. The Chemo Duck ... devices, is filled with enjoyable games to help children of all ... free app helps to keep kids entertained, educated and at ease ...
(Date:1/22/2015)... 2015 VogueQueen is a seasoned and trusted ... many designers are thrilled to have it lead the wedding ... new collection of prom dresses for the global market. , ... strategic vision and he focuses on continuing the goal of ...
(Date:1/22/2015)... Angelweddingdress is a famous wedding dress company offering many trendy ... on Facebook, Twitter, and Pinterest. The fans will have an ... lottery every week. , Moreover, the company has extended its ... Angelweddingdress homepage for more information. , Angelweddingdress is ...
(Date:1/22/2015)... AngelWeddingDress, the premier women’s dress supplier, has recently released ... website of AngelWeddingDress.com to find more details. , ... for a bridal party. AngelWeddingDress offers a variety of ... maternity wedding dresses are specially designed for 2015. , ...
(Date:1/22/2015)... Juvent Sports ( http://www.juventsports.com ) and ... Merchandise Show to bestow a Juvent Sports Achievement award ... Arlene McKitrick. The award commemorated and congratulated McKitrick for ... She won her first amateur tournament in 1979 and ...
Breaking Medicine News(10 mins):Health News:Chemo Duck Launches First App Ever Created for Kids with Cancer 2Health News:Chemo Duck Launches First App Ever Created for Kids with Cancer 3Health News:VogueQueen Unveils New Designs of Prom Dresses for 2015 2Health News:Angelweddingdress Invites Its Customers To Follow It On Facebook, Twitter, And Pinterest 2Health News:AngelWeddingDress Has Recently Released Its Collection Of 2015 Maternity Wedding Dresses 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 3
... of metastatic breast cancer shows that the number of ... correlates with the length of their survival. Reported at ... results have the potential to improve the delivery of ... --cancer cells found in a patient,s bloodstream-- are detected ...
... comes to talking to parents about most dating issues, teen girls ... to talk to their mothers. However, a new study found ... and what they do with their dates while unsupervised. And in ... mothers than they were their fathers. Results showed that ...
... Renal ... U.S. – is advancing a robust growth strategy amidst a sluggish economy, opening four new ... ... (RAI) – the third largest for profit provider of dialysis services in the U.S. – ...
... ... care that nurses provide every day, FreshDirect, the leading online fresh-from-the-farm food and grocery ... a very special gift of ready-to-heat-and-serve 4-Minute Meals to nurses at five community hospitals ... ...
... drinking habits, researcher says , THURSDAY, May 6 (HealthDay News) ... reported link with a type of kidney cancer, you can relax. ... in this study provide no concrete evidence of a need to ... Timpson, a lecturer in genetic epidemiology at the University of Bristol ...
... imaging test of choice when evaluating patients with foot drop ... causing uncontrolled slapping of the foot while taking a step), ... 2010 Annual Meeting in San Diego, CA. Ultrasound imaging is ... ultrasound waves to produce pictures of inside the body. ...
Cached Medicine News:Health News:Survival in metastatic breast cancer directly linked to circulating tumor cells 2Health News:Teen girls talk more to parents about their dating habits than do boys 2Health News:Teen girls talk more to parents about their dating habits than do boys 3Health News:Renal Advantage Inc. (RAI) has Solid Growth, Opens 6 New Centers in 4 Months 2Health News:Renal Advantage Inc. (RAI) has Solid Growth, Opens 6 New Centers in 4 Months 3Health News:FreshDirect Celebrates Nurse Appreciation Week with Delivery of Complimentary 4-Minute Meals for Nurses at Hospitals in Westchester and Greenwich, CT 2Health News:FreshDirect Celebrates Nurse Appreciation Week with Delivery of Complimentary 4-Minute Meals for Nurses at Hospitals in Westchester and Greenwich, CT 3Health News:Study Disputes Link Between Milk and Kidney Cancer 2
(Date:1/22/2015)... privately held medical device company, announced today that it ... Corporation (Tokyo Stock Exchange TYO: 8001) to sell its ... in Japan . ViewRay,s technology, the ... MRI-guided radiation therapy system that images and treats cancer ...
(Date:1/22/2015)... /PRNewswire/ - Pivotal Therapeutics Inc. (OTCQX:PVTTF; CSE:PVO), ("Pivotal" or the "Company"), ... for cardiovascular disease and overall health is pleased to provide ... and its outlook for 2015 from the CEO, Mr. ... We would like to take this opportunity to share with ...
(Date:1/22/2015)... , Jan. 22, 2015 Increasing sophistication among enterprise ... of localization purchasing in 2015, says Moravia ... a recent study by market research firm Common Sense ... solution for their translation and localization needs. "From a ...
Breaking Medicine Technology:ITOCHU Named the Exclusive Distributor for ViewRay's MRI-Guided Radiation Therapy System in Japan 2Pivotal Therapeutics: Year in Review and CEO Update 2Pivotal Therapeutics: Year in Review and CEO Update 3Pivotal Therapeutics: Year in Review and CEO Update 4Pivotal Therapeutics: Year in Review and CEO Update 5Pivotal Therapeutics: Year in Review and CEO Update 6Pivotal Therapeutics: Year in Review and CEO Update 7Moravia Sees Single-Sourcing as Key Localization Trend in 2015 2
... , SAN DIEGO , July 22 Neurocrine Biosciences, Inc. ... quarter 2010 financial results after the Nasdaq market closes on Wednesday, July ... to discuss its financial results and provide a Company update Thursday morning, ... a.m. Pacific Time ). , , ...
... 22 VirtualScopics, Inc. (Nasdaq: VSCP ), ... announced today that it has been added to the ... to provide a comprehensive and unbiased barometer for the ... in the Russell Microcap Index, which remains in place ...
Cached Medicine Technology:Neurocrine Biosciences Announces Conference Call and Webcast to Report Second Quarter 2010 Financial Results 2VirtualScopics Added to Russell Microcap Index 2VirtualScopics Added to Russell Microcap Index 3VirtualScopics Added to Russell Microcap Index 4
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... 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 ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... 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 ...
Medicine Products: