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AstraZeneca to participate in FDA PDAC meeting

31 Mar 2009

AstraZeneca is due to take part in a US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) meeting, which has been tentatively scheduled for June 9th and 10th.

The company has been told the panel will discuss the efficacy and safety of supplemental new drug applications for the treatment Seroquel, which has been proposed for the management of schizophrenia in adolescents.

It has also been put forward as a treatment for bipolar mania in children and young teenagers.

"AstraZeneca fully supports the work of the FDA in conducting a full review of the potential benefits and risks of Seroquel," the company said.

The therapy is not currently approved for paediatric use in any country, but has been given the green light for use in adults with depressive episodes of bipolar disorder and schizophrenia.

Earlier this month, the pharmaceutical firm published its annual report and announced its annual general meeting will take place on April 30th.