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Schaeffer's Street Stories: AstraZeneca plc Plunges on FDA Concerns Regarding Seroquel Approval

  //health-fitness.news-articles.net/content/2009/ .. on-fda-concerns-regarding-seroquel-approval.html
  Published in Health and Fitness on Friday, February 27th 2009 at 8:20 GMT, Last Modified on 2009-02-27 08:21:08 by Market Wire

CINCINNATI--([ BUSINESS WIRE ])--The shares of AstraZeneca plc (NYSE: AZN) have dropped 3.4% this morning following news that the firm received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) asking for additional information for the use of Seroquel XR to treat generalized anxiety disorder. In a statement, the company said, "AstraZeneca is evaluating the contents of the CRL and the proposed labeling revisions."

Seroquel XR is the slow-release version of the company's powerful psychiatric drug Seroquel. The drug was first launched in 1997, and has become the pharmaceutical company's second-best selling product, with sales of $4.5 billion in 2008. Seroquel XR was approved in the U.S. in 2007 for the treatment of schizophrenia in adult patients, and in October 2008 for the treatment of bipolar disorder.

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