Seroquel News and Research

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Seroquel is a drug approved to treat acute depressive episodes in bipolar disorder; acute manic or mixed episodes in bipolar disorder alone or when added to lithium or divalproex; long-term maintenance of bipolar disorder when added to lithium or divalproex; and schizophrenia.

FDA approves once-daily SEROQUEL XR Extended Release Tablets

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR® (quetiapine fumarate) Extended Release Tablets as adjunctive (add-on) treatment to antidepressants in adults with Major Depressive Disorder (MDD).

4 Dec 2009

Generic erosion to decrease branded atypical antipsychotics schizophrenia drug market to $5.2B

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that generic erosion of several established branded atypical antipsychotics will cause the schizophrenia drug market to decrease from $6.3 billion in 2008 to $5.2 billion in 2013 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

2 Dec 2009

Antipsychotic medications increase the levels of inflammation markers, find researchers

Overall, antipsychotic medications are reasonably effective, and fairly well tolerated treatments for mood and psychotic disorders. However, treatment with a number of antipsychotic medications is associated with weight gain, and for some, hyperglycemia and hyperlipidemia.

2 Dec 2009

Psychiatrist delivers high-risk meds, poor care in Chicago nursing homes

ProPublica/The Chicago Tribune examine the case of a controversial psychiatrist who delivered an anti-psychotic medication to thousands of Medicaid patients in Chicago's nursing homes. "Dr. Michael Reinstein is one of the most prolific providers of psychiatric care in Chicago-area nursing homes and mental health facilities. But he is trailed by lawsuits and complaints while getting government reimbursement for seeing a large number of patients."

12 Nov 2009

Bipolar disorder drug market to decline from $6.3 billion to $5 billion

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that widespread generic erosion of branded atypical antipsychotics will cause the bipolar disorder drug market to decline from $6.3 billion in 2008 to approximately $5 billion in 2018 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

6 Nov 2009

AstraZeneca bolsters revenue with Toprol-XL and H1N1 vaccine sales

AstraZeneca, Third quarter revenue increased by 10 percent at constant exchange rates (CER) to $8,200 million.

29 Oct 2009

Teva to market generic version of AstraZeneca's antipsychotic agent Seroquel tablets

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Court of Appeals for the Federal Circuit has affirmed a July 1, 2008 decision by the District Court to grant AstraZeneca’s motion for summary judgment of no inequitable conduct related to U.S. Patent No. 4,879,288.

26 Sep 2009

Pfizer pleads guilty of defrauding Medicare, Medicaid and other government-funded health care programs

Pfizer, Inc. announced today it has agreed to plead guilty to criminal conduct and to pay more than $2 billion in criminal and civil fines, penalties and damages to settle allegations made in multiple whistleblower lawsuits that the pharmaceutical giant defrauded Medicare, Medicaid and other government-funded health care programs in connection with its market practices for four of its drugs. The settlement is the largest qui tam settlement in U.S. history.

3 Sep 2009

Physicians lack knowledge of off-label drug use and FDA approval status

In a recent national survey, a substantial minority of physicians erroneously believed that certain off-label uses of prescription drugs were approved by the Food and Drug Administration. This mistaken belief could encourage them to prescribe these drugs, despite the lack of scientific evidence supporting such use.

21 Aug 2009

Seroquel XR supplemental NDA recommended for approval

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).

9 Apr 2009

St. Petersburg Times examines decline in antipsychotic drug prescriptions for Florida children

St. Petersburg Times recently examined how since the Florida Medicaid program last year began requiring physicians to receive approval before prescribing antipsychotic drugs to children younger than age six, the number of prescriptions for children in that age group has dropped by nearly 75%, according to new data from the Florida Agency for Health Care Administration.

31 Mar 2009

Add-on treatment may reduce treatment-associated weight gain caused by antipsychotic treatments

Antipsychotic drugs, such as olanzapine (Zyprexa), risperidone (Risperdal) and quetiapine (Seroquel), are commonly used to treat psychotic disorders like schizophrenia, but also bipolar disorder and even behavioral problems related to dementia.

29 Mar 2009

New plan to tackle off-label prescribing

Physicians and policy-makers know that drugs are frequently prescribed to treat certain diseases despite a lack of FDA approval - a practice known as off-label prescribing.

24 Nov 2008

Warning about use of psychiatric drugs with the elderly

Health officials in the U.S. are warning doctors that prescribing certain psychiatric drugs to elderly people suffering from dementia can increase their risk of death.

17 Jun 2008

Antipsychotic drugs get FDA label changes

The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia.

16 Jun 2008

Antipsychotic drugs dangerous for the elderly

A Canadian study has found that prescribing antipsychotic drugs for elderly people may be dangerous.

27 May 2008

AstraZeneca submits sNDA for SEROQUEL XR for treatment of major depressive disorder

AstraZeneca has announced the submission of a supplemental New Drug Application (sNDA) 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 major depressive disorder (MDD) as monotherapy, adjunct therapy, and maintenance therapy in adult patients.

1 Mar 2008

AstraZeneca submits sNDAs for SEROQUEL XR for bipolar symptoms

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.

3 Jan 2008

Seroquel XR tablets approved in Netherlands for the treatment of schizophrenia

AstraZeneca today announced the Netherlands regulatory authority MEB (Medicines Evaluation Board) has approved Seroquel XR (quetiapine fumarate) Extended-Release Tablets, a once-daily medicine for the treatment of schizophrenia in adult patients.

29 Aug 2007

FDA - all antidepressants need new warning labels

The Food and Drug Administration (FDA) in the United States wants the manufacturers of antidepressant medications to change the labels on their products.

3 May 2007