WASHINGTON — AstraZeneca’s Seroquel (quetiapine fumarate) was approved on Friday by the U. S. Food and Drug Administration on the market but will be a first for the drug. The drug’s generic version — known as Quetiapine Fumarate — is not yet approved for sale in the United States.
The drug’s label may soon include a generic version of the drug, which is approved to treat schizophrenia. Seroquel, also known as quetiapine, is a type of antipsychotic drug and is available as an oral tablet. AstraZeneca’s Seroquel, an extended-release version of quetiapine, is available for generic use in the U.
“We believe it is an excellent and valuable drug for people with schizophrenia or bipolar disorder and are pleased to have an opportunity to offer this important treatment option to the millions of patients in this country,” said Michael R. Schott, AstraZeneca’s chairman and chief executive officer. “The availability of generic versions of Seroquel will benefit patients in this country with bipolar disorder, who are on their own, or may be at risk for being on Seroquel.”
Schott added that the company is working closely with the U. Food and Drug Administration on its drug to develop a new treatment for this condition.
Schott said the U. government has requested that the agency approve Seroquel for sale in the U. S., and is working with the FDA to determine whether to approve the drug for this treatment. AstraZeneca has submitted data showing Seroquel sales of $2.7 billion, or 36 percent of its total sales, in the U. The company also expects to file an application for approval for the generic version of Seroquel on June 24.
The company said it is working on its second drug for schizophrenia, known as Seroquel SR, and is looking to market a generic version of Seroquel for that condition.
Seroquel sales will total $1.6 billion, up 5.8 percent from last year, according to data from IMS Health. The company said the company plans to file its third Seroquel application for generic quetiapine.
The company said the company will work with the FDA to determine whether to approve Seroquel for the treatment of schizophrenia.
The company said its Seroquel sales will be on top of its earnings estimates for the fourth quarter and the full year. The company also said it is reviewing its third Seroquel application for generic quetiapine.
The company said Seroquel sales of $3.1 billion were in line with the company’s estimates for its fourth quarter and full year.
“Our strategy for working closely with the FDA to approve Seroquel for generic quetiapine is progressing and we look forward to continuing to deliver on our promises,” said Dr. Robert R. Lechleiter, a spokesman for AstraZeneca.
Schott said he is pleased that the company is reviewing the application and is working closely with FDA to approve it.
“We are working with the FDA to ensure that the approval of this drug is effective for patients with serious illnesses and are taking reasonable steps to minimize the risk of adverse events associated with the drug,” he said.
Schott added that the company is reviewing its Seroquel application to ensure that it is working with the FDA to determine whether to approve the treatment of schizophrenia. He also said the company is working with the FDA to consider whether to approve Seroquel for use in children under the age of 12.
The company said it will work with the FDA to determine whether the generic version of Seroquel is safe and appropriate for use.
Originally Published: May 28, 2007 at 9:00 AM EDT
The Associated PressSeroquel, a brand name for Seroquel (quetiapine fumarate), was approved by the U. Food and Drug Administration on Friday to treat schizophrenia. Its generic form, quetiapine, is not yet available.
The company announced the approval of Seroquel in late March.
ByJulie K. Smith
Seroquel XR (quetiapine fumarate) is an atypical antipsychotic medication, used to treat conditions such as schizophrenia and bipolar disorder. Seroquel XR is a combination of two drugs, quetiapine fumarate and clozapine, which work together to reduce the symptoms of schizophrenia and bipolar disorder. Seroquel XR may also be used for other uses.
Seroquel XR works by blocking dopamine receptors in the brain, which helps improve thinking, mood, and behavior. It is usually taken as a single dose of 2.5 mg, followed by a 2.5 mg or 5 mg daily dose in increments of 5 mg to treat schizophrenia and bipolar disorder.
Seroquel XR is used to treat conditions such as schizophrenia and bipolar disorder.
IMPORTANT NOTE:The American Urological Association (AUA) has approved this drug for the treatment of dementia. The AUA has not approved this medication for the treatment of mental disease.
Citation:Hil overdoses from quetiapine fumarate overdose. Qnesium: A new non-pharmacological treatment for dementia.
SUNDAY, NEW JERSEY (AP) —
The US Food and Drug Administration (FDA) approved Seroquel XR (quetiapine fumarate) in August 2009 to treat mental illnesses and schizophrenia. It’s the first new indication for the drug since 1997’s Effexor, the first new indication for the treatment of dementia.
The company says it can treat bipolar disorder in addition to schizophrenia and mental illness as a treatment for bipolar disorder.
Seroquel XR has been approved to treat bipolar disorder since 1997. It’s the first new indication for the treatment of dementia since its approval in July 2009.
Seroquel XR can also be used in combination with other medications to treat bipolar disorder, schizophrenia, and other mental disorders. It’s usually taken orally, with or without food. The drug works by increasing the levels of dopamine in the brain and other important brain chemicals. Dopamine is responsible for mood regulation, sleep, and attention.
Seroquel XR has been approved to treat bipolar disorder in adults and children 18 years of age and older. Children under 18 years of age are not prescribed this drug.
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INDICATION
Seroquel XR is indicated for the treatment of schizophrenia and mental disorder in adults and children 18 years of age and older. It’s the first new indication for the treatment of dementia since 1997’s Effexor.
Seroquel XR should be used as first-line therapy for schizophrenia and mental disorder in adults and children 18 years of age and older. It should not be used for the treatment of dementia.
WARNING
Seroquel XR should be used with caution in children under age 18 years. The risks of overdose with Seroquel XR are not known.
Seroquel XR may cause drowsiness, drowsiness, or dizziness in some patients. Patients should be advised to use caution and avoid driving, operating machinery, or any other hazardous activity until the adverse effects of Seroquel XR are known.
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