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Home Industry News AstraZeneca announces approval of formulations

AstraZeneca announces approval of formulations

13th November 2008

AstraZeneca has today announced its formulations, Seroquel and Seroquel XR, have been approved for treatment in Europe.

Under the European Mutual Recognition Procedure, the once-daily formulations can now be used for the treatment of bipolar disorder on the continent.

Seroquel (quetiapine fumarate) and Seroquel XR’s (quetiapine fumarate extended release tablets) approval is set to see use for major depressive episodes that are part of the disorder, with the latter licensed for moderate to severe manic episodes.

The announcement follows the October approval of Seroquel XR by the US Food and Drug Administration, with Seroquel itself currently the only atypical antipsychotic approved to treat mood episodes associated with bipolar disorder.

It is also the only licensed treatment for bipolar depression in Europe.

The Seroquel’s mechanism of action, which involves both antidepressant and antipsychotic activities, has efficacy across a range of mood episodes associated with bipolar disorder.

AstraZeneca employs over 67,000 people, with 55 per cent in Europe, 33 per cent in North, Central and South America and 15 per cent in Asia, Australasia and Africa.

The company’s sales in 2007 totalled $29.6 billion (19.8 billion pounds), seeing an operating profit of $9 billion, with the company spending more than $5 billion on research and development in 2007.

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