Navigation Links
AstraZeneca Submits sNDA for SEROQUEL XR(TM) for the Treatment of Major Depressive Disorder
Date:2/29/2008

riteria including the MADRS. Doses of 50 mg, 150 mg and 300 mg of SEROQUEL XR were studied in the MDD program.(4)

In 2007, SEROQUEL XR was approved in the U.S. for the treatment of schizophrenia in adult patients and for maintenance treatment of schizophrenia in adult patients. Last month, AstraZeneca announced the submission of two separate sNDAs to the FDA for SEROQUEL XR to seek approval for the treatment of manic episodes associated with bipolar disorder and the treatment of depressive episodes associated with bipolar disorder. The FDA has not completed its review of these submissions. In addition to the submission for MDD, clinical development programs are ongoing and regulatory filings are planned for SEROQUEL XR in other indications.

Launched in 1997, SEROQUEL(R) (quetiapine fumarate tablets) has been prescribed to millions of patients worldwide. It is approved in 88 countries for the treatment of schizophrenia, in 79 countries for the treatment of bipolar mania, and in 11 countries including the U.S. for the treatment of bipolar depression.

Important Safety Information for SEROQUEL and SEROQUEL XR

SEROQUEL XR is indicated for the acute and maintenance treatment of schizophrenia. SEROQUEL is indicated for the treatment of depressive episodes in bipolar disorder; acute manic episodes in bipolar I disorder, as either monotherapy or adjunct therapy to lithium or divalproex; and schizophrenia. Patients should be periodically reassessed to determine the need for treatment beyond the acute response.

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death, compared to placebo (4.5% vs 2.6%, respectively). SEROQUEL and SEROQUEL XR are not approved for the treatment of patients with dementia-related psychosis. (See Boxed Warning.)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults
'/>"/>

SOURCE AstraZeneca
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related biology technology :

1. Pediatric Asthma Programs Featuring PARI Pharmas eFlow Acquired by AstraZeneca
2. AstraZeneca Bolsters Its Worldwide Biologics Division Through Integration of Cambridge Antibody Technology Into MedImmune
3. AstraZeneca and Banner Alzheimers Institute Collaborate to Evaluate New Tool Targeting Alzheimers Disease
4. Epistem plc and AstraZeneca Complete Plucked Hair Biomarker Study for Oncology Drug Development
5. Meditrina Pharmaceuticals, Inc. Announces Exclusive Global License Agreement With AstraZeneca
6. AstraZeneca Response to February 21, 2008 Ruling In Re: Alabama Medicaid Pharmaceutical AWP Litigation - cv2005-219 - Circuit Court of Montgomery, Alabama
7. Exelixis Submits XL880 Diligence Report to GlaxoSmithKline
8. Cephalon Submits New Drug Application for TREANDA for the Treatment of Chronic Lymphocytic Leukemia
9. CV Therapeutics Submits Supplemental New Drug Application for Ranexa(R) (ranolazine extended-release tablets)
10. AMDL Submits Data to FDA for Clearance to Market Its DR-70(R) Diagnostic Test to Monitor Colorectal Cancer Patients
11. Cephalon Submits Supplemental New Drug Application for FENTORA
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/28/2015)... 28, 2015  Faced with increasing challenges such ... rather than symptomatic, the global healthcare industry today ... capable of curing or significantly changing the course ... look towards regenerative medicine as a viable alternative. ... in human health with the potential to resolve ...
(Date:7/27/2015)... and FRANKLIN, Tenn. ... a privately-owned  premier provider of health care services ... in the U.S., today announced that its parent ... signed a definitive agreement with Medical Properties Trust, ... acquisition of Capella for $900 million in cash.  The transaction ...
(Date:7/27/2015)... ... July 27, 2015 , ... This is a ... provides a basic overview of the industry including definitions, classifications, applications and industry ... development trends, competitive landscape analysis, and key regions development status. Development policies and ...
(Date:7/27/2015)... ... July 27, 2015 , ... ... announced a new video: 3 Ways to GHS Labels . This video ... the Globally Harmonized System (GHS) by effectively labeling chemical containers. , “With the ...
Breaking Biology Technology:Stem Cell Therapy to Redefine Regenerative Medicine, says Frost & Sullivan 2Stem Cell Therapy to Redefine Regenerative Medicine, says Frost & Sullivan 3Stem Cell Therapy to Redefine Regenerative Medicine, says Frost & Sullivan 4Stem Cell Therapy to Redefine Regenerative Medicine, says Frost & Sullivan 5Capella Healthcare Announces Agreement With Medical Properties Trust, Inc. 2Capella Healthcare Announces Agreement With Medical Properties Trust, Inc. 3Capella Healthcare Announces Agreement With Medical Properties Trust, Inc. 4Capella Healthcare Announces Agreement With Medical Properties Trust, Inc. 52015 Biophotonics Market Global Research 22015 Biophotonics Market Global Research 3Brady Releases “3 Roads to GHS Labels” Video 2
... , , MURRIETA, Calif., Aug. ... announce the expansion of its US operations. Copan Diagnostics, Inc. ... plastic transfer pipet and additional medical device manufacturing operations to ... addition of blow molding machinery and filling and packing equipment ...
... , , , , ... PPHM ) today announced that it will release its financial results for ... 7:00 a.m. EDT and will host a conference call and webcast to ... , Peregrine,s senior management will discuss financial results for ...
... , , ... maker of the world,s best ruggedized cell phones, announces the ... of 2009. Airo is releasing the A25is for people in ... Fertilizer, Coal, Propane, Fuel Distribution, Refineries, Paint Processing, Granaries, Mining, ...
Cached Biology Technology:Copan Announces Multimillion Expansion for US Pipet Manufacturing Operations 2Peregrine Pharmaceuticals to Report First Quarter FY 2010 Financial Results 2Airo Wireless Announces the Release of the Intrinsically Safe A25is Cell Phone/PDA 2
(Date:7/13/2015)... , July 13, 2015 Synaptics ... of human interface solutions, today announced sampling of ... and display driver integration (TDDI) product targeting smartphones ... first to combine Synaptics , best-in-class touch ... display driver technology developed in the company,s Japan ...
(Date:7/9/2015)... , July 9, 2015  Synaptics Inc. (NASDAQ: SYNA ... today that it will report financial results for the ... 30, 2015 after the close of market. The company ... investors at 2:00 p.m. PT (5:00 p.m. ET), during ... To participate on the live call, analysts and investors ...
(Date:7/9/2015)... 9, 2015  Unchained Labs just can,t get ... of Avid Nano. Avid Nano designs, develops and ... Also today, Unchained Labs UNcaged ... to use protein sizing system. The pUNk is ... hydrodynamic size, size distribution, aggregation population and molecular ...
Breaking Biology News(10 mins):Synaptics Announces Sampling of Second Generation TDDI Solutions 2Synaptics Announces Sampling of Second Generation TDDI Solutions 3Synaptics to Report Fourth Quarter, Fiscal Year 2015 Results on July 30 2Unchained Labs just can't get enough, acquires Avid Nano, rocks out the new pUNk! 2
... are said to be hydrophobic. The hydration or ... important for many biological processes: protein folding, membrane formation, ... action potentials across membranes. It is involved as well ... fact that you can get rid of fat with ...
... of Southampton are to undertake a new stage of a ... suffering from the common complaint of ,walking on marbles, associated ... the second most common form of arthritis in the UK, ... joints around the body caused by inflammation. Forefeet ...
... breathing problems after birth, and rare, inherited DNA differences may ... Medicine in St. Louis. The study is the first ... associated with a significant number of cases of respiratory distress ... RDS is the most common respiratory problem in newborns and ...
Cached Biology News:Illuminating the no-man's land of waters' surface 2'Walking on marbles' could be a thing of the past for arthritis patients 2Gene linked to respiratory distress in babies 2Gene linked to respiratory distress in babies 3
... of environmental and pathophysiological stressful conditions trigger ... known as heat shock proteins (HSPs), more ... The Hsp90 family of proteins in ... beta, Grp94, and Trap-1 (Hsp75). It was ...
Custom LNA Oligonucleotide synthesis ,High quality Custom LNA Oligonucleotides are available for a variety of different specialty applications and innovative products. ,Please inquire for further...
... Service, We deliversoluble protein or No ... yields the best soluble protein results , ... clone submitted , Powerful results on your ... Solubility Optimization Service (SOS) uses proprietary tools ...
... for proteomic scale kinase profiling, quantitative ... drug discovery research built on the ... synthesis platform. These microarrays are available ... Kinase Substrate - Peptide Microarray Service. ...
Biology Products: