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FDA committee to discuss AstraZeneca drug applications

26 Feb 2009

The US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee is scheduled to convene on April 8th, it has been announced.

AstraZeneca notes that at the meeting, the body will discuss the efficacy and safety of supplemental new drug applications for the medication Seroquel XR, which has been proposed for the treatment of generalised anxiety disorder.

A once-daily extended-release formulation of its forerunner Seroquel, it is also put forward as a therapy for major depressive disorder.

The pharmaceutical company states: "AstraZeneca fully supports the work of the FDA in conducting a full review of the potential benefits and risks of Seroquel XR in the treatment of major depressive disorder and generalised anxiety disorder."

In January, AstraZeneca announced its fourth-quarter and full-year results for 2008, stating it delivered a "robust" performance, as well as making "good headway" in improving its efficiency.

For the year ended December 31st, it noted revenue of $31.6 billion (£22.03 billion).