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

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.

To continue reading this article, click here: [ http://www.schaeffersresearch.com/commentary/content/astrazeneca+plc+plunges+on+fda+concerns+regarding+seroquel+approval/observations.aspx?click=home&ID=91446&source=businesswire ]



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