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Home Industry News AstraZeneca reports Seroquel XR approval

AstraZeneca reports Seroquel XR approval

30th August 2007

AstraZeneca has announced that the Medicines Evaluation Board (MEB) of the Netherlands has granted marketing approval for Seroquel XR (quetiapine fumarate) extended-release tablets as a treatment for schizophrenia.

The MEB approval includes the prophylaxis of relapsing in the long-term treatment of the disease.

Following this decision from the Netherlands regulatory authority, the company will seek similar approvals across Europe through the mutual recognition procedure.

The decision from the regulator followed clinical trials of the compound assessing its safety and efficacy in acute treatment and relapse-prevention at 400 mg/day, 600 mg/day and 800 mg/day doses.

Clinical studies also included a non-inferiority assessment of Seroquel XR compared to the original formulation of the drug.

“Seroquel XR has been developed with the aim of improving dosing and titration options for patients and their doctors as they face the challenge of achieving successful treatment of schizophrenia,” AstraZeneca reports.

The firm notes that the original formulation of Seroquel has been used to treat over 19 million patients across the globe since its 1997 launch.

In March 2007, AstraZeneca presented clinical trial data to the European Congress of Psychiatry showing that Seroquel improved the symptoms in schizophrenia patient when measured by the Positive and Negative Syndrome Scale.

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