Astra's Seroquel wins wider European approval

Thu Nov 13, 2008 8:04pm GMT
 
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* Seroquel XR and Seroquel approved for new bipolar uses

* Approvals under European Mutual Recognition Procedure

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LONDON (Reuters) - AstraZeneca Plc (AZN.L) has won European approval for wider use of both the original and the new version of its blockbuster schizophrenia drug Seroquel in treating bipolar disorder.

The Anglo-Swedish company said on Thursday that Seroquel XR and Seroquel had been approved for major depressive episodes in bipolar disorder, while Seroquel XR is licensed for moderate to severe manic episodes.

The approvals were obtained under the European Mutual Recognition Procedure (MRP) and AstraZeneca will now push ahead with securing local approvals with the 17 states that take part in the MRP.

The latest green light for Seroquel XR -- an extended-release version of the original product -- follows the October 2008 approval of the medicine in similar indications by the U.S. Food and Drug Administration.

Seroquel is the company's second-biggest selling drug, generating $4 billion of sales in 2007.

However, it has been under threat from generic drugmakers seeking to sell cheap copies and AstraZeneca wants to promote the newer XR form, which has a longer patent life.

(Reporting by Ben Hirschler; Editing by Hans Peters)

 

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