AstraZeneca P.L.C. said yesterday that Dutch regulators rejected its application to market its Seroquel XR as a treatment for major depression, dealing a blow to the company's hopes to market the schizophrenia drug for that purpose across Europe.
Under European Union rules, approval in one country clears the way for marketing authorizations across the region.
The company could still get the drug approved for this use in Europe, however, and said it will apply to do so.
In April, a U.S. Food and Drug Administration advisory panel recommended that Seroquel XR be approved as an additional medication to treat depression in patients not responding to current drugs.
But the FDA panel denied the London company's bigger request to treat depression and anxiety as a single therapy.
The company's U.S. headquarters are in Wilmington. - Miriam Hill