AstraZeneca Seeks Additional Seroquel Approvals in EU

AstraZeneca has filed an application in the European Union (EU) for Seroquel XR to treat bipolar manic episodes and bipolar depressive episodes.

The company filed supplemental new drug applications for the same indications with the FDA earlier this year. Last year, the FDA approved Seroquel XR (quetiapine fumarate) to treat schizophrenia, giving the extended-release formulation of the drug patent protection until 2017.

In addition, the company filed an application in the EU for immediate-release Seroquel  to treat bipolar depression. The FDA approved Seroquel for that indication last year.