AstraZeneca refers Seroquel XR drug application

AstraZeneca’s submission to the Netherlands Health Authority for the use of Seroquel XR (quetiapine fumarate) to treat major depressive disorder (MDD) has been refused.

Because of this, the company has referred its application of the extended release tablets to the committee for medicinal products for human use (CHMP) ? which is part of the European Medicines Agency.

The marketing application for the drug was to help MDD patients manage recurrent depressive episodes that are not appropriately assisted by the use of alternative remedies.

Based on data from clinical trials, AstraZeneca believes the medication has the potential to treat people with the condition.

Seroquel XR has recently been approved by the Canadian Regulators for the medical problem in adults.

Last month, the CHMP recommended the company’s drug Iressa could be used to assist patients with locally advanced or metastatic non-small cell lung cancer.

Executive vice-president for development at the firm Anders Ekblom remarked the positive opinion was a significant step “towards addressing the great unmet medical need” of patients in Europe.