Antipsychotic given green light for teens
4 February 2010
| by Sarah Colyer
The Australian Drug Evaluation Committee has backed an application for an antipsychotic drug to be approved for use in children with schizophrenia.
Following the lead of the US Food and Drug Administration in December, the committee recommended quetiapine fumarate (Seroquel) be approved for registration for patients aged 13 to 17 for the treatment of schizophrenia, and for patients aged 10 to 17 with acute mania associated with bipolar 1 disorder.
The recommendation follows four paediatric trials of the drug, evaluating its safety and efficacy in children and adolescents.
In addition, the committee recommended an extended-release version of the drug (Seroquel XR) be approved for registration to treat general anxiety in adults in whom alternative therapies were not well tolerated or not effective....
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