Corporate Banner
Satellite Banner
Medicinal Chemistry
Scientific Community
Become a Member | Sign in
Home>News>This Article

AstraZeneca Submits sNDAs for Seroquel XR™ for the Treatment of Bipolar Mania and Bipolar Depression

Published: Thursday, January 03, 2008
Last Updated: Thursday, January 03, 2008
Bookmark and Share
AstraZeneca has submitted two separate supplemental New Drug Applications to the US FDA for once-daily Seroquel XR™ Extended-Release Tablets.

AstraZeneca has announced that the company has submitted two separate supplemental New Drug Applications (sNDAs) to the U.S. Food and Drug Administration (FDA) for once-daily SEROQUEL XR™ (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of manic episodes associated with bipolar disorder and the treatment of depressive episodes associated with bipolar disorder.

The bipolar mania submission is based on a clinical study of once-daily treatment with SEROQUEL XR, compared to placebo, with a primary endpoint of change in YMRS (Young Mania Rating Scale) total score (week 3), in 316 patients suffering from bipolar mania.

The bipolar depression submission is supported by a clinical study of once-daily treatment with SEROQUEL XR, compared to placebo, with a primary endpoint of change from baseline in MADRS (Montgomery Asberg Depression Rating Scale) total score after eight weeks of treatment, in 280 patients diagnosed with bipolar depression.

Doses of SEROQUEL XR administered in both the bipolar mania (400 mg to 800 mg/day) and bipolar depression (300 mg/day) studies were comparable to the FDA-approved recommended doses for SEROQUEL (quetiapine fumarate) immediate release tablets in those indications. Both studies met their primary endpoint and it is expected that they will be presented at major scientific congresses in 2008.

SEROQUEL XR is currently approved in eight countries including US, Canada and The Netherlands, for the acute and maintenance treatment of schizophrenia in adults.

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,800+ scientific posters on ePosters
  • More than 4,000+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

AstraZeneca Buys Rights to Almirall Respiratory Franchise
AstraZeneca agrees an initial consideration of $875 million on completion, which may rise to $1.22 billion in development, launch, and sales-related milestones.
Monday, August 04, 2014
AstraZeneca Reveals Designs for Cambridge Headquarters
Company revealed the proposed designs for its new Global R&D Centre and Corporate Headquarters in Cambridge in the UK.
Friday, July 18, 2014
AstraZeneca Board Rejects Pfizer Proposal
The financial and other terms of the proposal have been described as inadequate, substantially undervaluing AstraZeneca.
Friday, May 02, 2014
AstraZeneca to Acquire Bristol-Myers Squibb Share of Global Diabetes Alliance Assets
Global agreement strengthens AstraZeneca’s commitment to diabetes.
Monday, December 23, 2013
AstraZeneca Announces Changes to Senior Executive Team
Company’s President and Executive Vice President will leave the company at the end of January.
Monday, January 28, 2013
AstraZeneca Appoints Pascal Soriot CEO
Pascal Soriot will take on his new responsibilities and join the AstraZeneca PLC Board as an Executive Director on 1 October 2012.
Tuesday, August 28, 2012
AstraZeneca to Provide UK Academics with Access to Compound Library
Their groundbreaking new collaboration with the Medical Research Council (MRC) will see the company providing the UK academic sector with access to 22 drugs.
Friday, December 09, 2011
Forest Laboratories and AstraZeneca to Co-Develop and Commercialize a Late Stage Next Generation Anti-Infective
The definitive collaboration agreement will co-develop and commercialize ceftaroline in all markets outside the U.S., Canada and Japan.
Thursday, August 13, 2009
IRESSA Receives Marketing Authorization for the Treatment of Non-Small Cell Lung Cancer in Europe
European Commission grants marketing authorization for the oral anti-cancer drug.
Tuesday, July 07, 2009
BioDuro and AstraZeneca Expand Collaboration to Optimize Discovery Research for Respiratory and Inflammation Indications
BioDuro and AstraZeneca announced that they have expanded their research collaboration to optimize discovery research for Respiratory and Inflammation indications.
Friday, March 27, 2009
AstraZeneca Licenses Antidepressant Compounds Discovered by Mayo Clinic and Virginia Tech Collaboration
The agreement provides AstraZeneca with a global license for all uses of the compounds, as well as exclusive manufacturing and commercial rights.
Tuesday, February 10, 2009
AstraZeneca and MAP Collaborate for Development and Commercialization of Unit Dose Budesonide
Unit Dose Budesonide is being developed as a potential treatment for pediatric asthma and is currently in Phase III clinical development.
Monday, December 22, 2008
AstraZeneca Announces Partnership with Singapore Institutions to Develop Anti-Cancer Compounds
The collaboration aims to further build AstraZeneca's drug development capabilities in Asia and speed up access to new medicines of potential benefit to patients.
Tuesday, August 19, 2008
Palatin Technologies Announces Amendment Expanding AstraZeneca Obesity Collaboration
AstraZeneca and Palatin amend their collaboration agreement to discover, develop and commercialize compounds that target melanocortin receptors.
Wednesday, July 02, 2008
AstraZeneca and Palatin Announce Collaboration to Discover, Develop and Commercialise Obesity Compounds
The collaboration is based on Palatin's melanocortin receptor Obesity programme and includes access to compound libraries, core technologies and expertise.
Tuesday, February 06, 2007
Scientific News
Drug May Prevent Life-Threatening Muscle Loss in Advanced Cancers
New data describes how an experimental drug can stop life-threatening muscle wasting (cachexia) associated with advanced cancers and restore muscle health.
Chemical Design Made Easier
Rice University scientists prepare elusive organocatalysts for drug and fine chemical synthesis.
Nanocarriers May Carry New Hope for Brain Cancer Therapy
Berkeley lab researchers develop nanoparticles that can carry therapeutics across the brain blood barrier.
Potential Persistent Tuberculosis Treatment
Researchers have discovered several first-in-class compounds that target hidden TB infections by attacking a critical process the bacteria use to survive in the hostile environment of the lungs.
Shedding Light on “Dark” Cellular Receptors
UNC and UCSF labs create a new research tool to find homes for two orphan cell-surface receptors, a crucial step toward finding better therapeutics and causes of drug side effects.
Giant Molecules Inhibit Ebola Infection
European researchers have designed a "giant" molecule formed by thirteen fullerenes covered by carbohydrates which, by blocking this receptor, are able to inhibit the cell infection by an artificial ebola virus model.
First Therapy Appearing to Reverse Decline in Parkinson’s
An FDA-approved drug for leukemia improved cognition, motor skills and non-motor function in patients with Parkinson’s disease and Lewy body dementia in a small clinical trial, say researchers at Georgetown University Medical Center (GUMC).
Fighting Pain with Ketamine
Researchers at the Texas A&M Health Science Center are using ketamine, a drug that already exists as an anesthetic, to treat pain.
Possible New Treatment for Neurodegenerative Diseases Found
Researchers at the University of Liverpool have found that a well-established anti-epileptic drug could also be used as a treatment for neurodegenerative diseases.
Breast Cancer Drug Beats Superbug
Tamoxifen helps white blood cells clear multidrug-resistant bacteria in lab and mouse studies.
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos