AstraZeneca’s Once-Daily Seroquel XR Approved in the Netherlands

AstraZeneca reported that the Netherlands’ Medicines Evaluation Board has approved Seroquel XR, a once-daily medicine for the treatment of schizophrenia in adult patients.

AstraZeneca said it will proceed with a mutual recognition procedure, seeking similar approvals across Europe.

The Medicines Evaluation Board’s approval was based on clinical trials evaluating effectiveness and safety at doses of 400, 600 and 800 mg per day in acute treatment, relapse prevention and also in a non-inferiority study when switching from the original formulation to Seroquel XR, the company said.

Ongoing clinical studies of Seroquel XR cover bipolar disorder, major depressive disorder and generalized anxiety disorder, the company added.

Seroquel XR was approved for the treatment of schizophrenia in the U.S. in May.