AstraZeneca's Seroquel and Seroquel XR get expanded indication in Europe

Anglo-Swedish drug major AstraZeneca says that Seroquel XR (quetiapine fumarate) extended-release tablets and the instant-release formulation of the atypical antipsychotic have both been approved in Europe for the treatment of major depressive episodes of bipolar disorder. Seroquel XR has also been cleared for moderate-to-severe manic episodes. The European Mutual Recognition Procedure approval follows on from last month's similar approval by the US Food and Drug Administration (Marketletter October 20). Seroquel XR is the slow-release version of AstraZeneca's Seroquel, the patent for which expires in 2011. The firm is hoping the XR drug, already approved for the treatment of schizophrenia, will help replace the $4.03 billion in sales that instant-release Seroquel generated last year.