AstraZeneca submits Seroquel SR US NDA
Anglo-Swedish drug major AstraZeneca has submitted a New Drug Application to the US Food and Drug Administration for a sustained-release, once-daily formulation of its antipsychotic drug Seroquel SR (quietiapine fumarate).
The clinical trials supporting the US submission used a short titration period that aimed at achieving a therapeutically-effective dose by the second day of treatment. The London-headquartered drug major also expects to make a submission to European regulators towards the end of the year. Seroquel is the most prescribed atypical antipsychotic, achieving global sales of $2.8 billion in 2005.
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