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FDA releases Seroquel XR findings

09 Apr 2009

The US Food and Drug Administration''s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) has released the results into its review of Seroquel XR - otherwise known as quetiapine fumarate.

According to the findings, the extended-release tablets proposed for the treatment of major depressive disorder (MDD) and generalised anxiety disorder (GAD) could be used adjunctively for the former.

The PDAC concluded that Seroquel XR be effective in treating both disorders as a monotherapy, however it did not find it acceptably safe for use in this manner.

Howard Hutchinson is chief medical officer at AstraZenica - the company that created the drug.

"We are pleased that the committee found Seroquel XR to be effective and acceptably safe for use as adjunctive therapy for the treatment of MDD," he said.

Mr Hutchinson went on to point out that the pharmaceutical firm intends to continue discussions with the FDA over its reservations about the treatment''s use as monotherapy.

In other news, the Royal Pharmaceutical Society of Great Britain has renewed its calls for the decriminalisation of dispensing errors.