Related Jobs
-
Technical Manager, Regulatory Affairs Development
Job Type: Permanent
Salary: Salary on application
Location: Belgium -
Director Regulatory Affairs
Job Type: Permanent
Salary: Excellent salary
Location: Switzerland
FDA to meet in June to discuss anti-psychotic drug
31 Mar 2009
Regulatory Affairs
The US Food and Drug Administration (FDA) is to meet in June to discuss AstraZeneca's application for approval of its anti-psychotic drug, Seroquel.
AstraZeneca is seeking authorisation of the medicine for the acute treatment of schizophrenia in young people aged 13 to 17 and as a therapy for bipolar mania in children and adolescents aged 10 to 17.
The regulatory body's psychopharmacologic drugs advisory committee has tentatively scheduled a meeting on June 9th and 10th, when it will consider the safety and efficacy of Seroquel based on the information submitted by the Anglo-Swiss firm.
"AstraZeneca fully supports the work of the FDA in conducting a full review of the potential benefits and risks of Seroquel," the company states.
The drug was approved in the US in 1997 as an anti-psychotic treatment for adults, but has not received authorisation for use by paediatric patients in any country.
AstraZeneca has also submitted an application to the FDA, hoping to gain consent to market Seroquel as a treatment for generalised anxiety disorder and major depressive disorder.
