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news.Anglo-Swedish drug maker AstraZeneca has submitted a new drug application to the FDA seeking approval for a sustained release formulation of its drug Seroquel for the treatment of schizophrenia.
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Seroquel tablets, in the currently available immediate release formulation, are approved for the treatment of acute manic episodes associated with bipolar I disorder and the treatment of schizophrenia.
In clinical trials supporting the FDA submission, the investigational once-daily formulation demonstrated an effective dose range of 400-800 mg/day. In addition, these trials aimed to show that an effective dose can be achieved as early as day two.
The company said that it expects to make a Seroquel SR filing in the European Union towards the end of 2006.
According to AstraZeneca, Seroquel has had more than 16 million patient exposures worldwide since its launch in 1997. In 2005, global sales for Seroquel reached $2.8 billion.