AstraZeneca's Seroquel XR get EC approval as add-on

LONDON Thu Sep 2, 2010 7:53am BST

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LONDON (Reuters) - Drugmaker AstraZeneca (AZN.L) said on Thursday the European Commission had approved Seroquel XR as an add-on treatment for major depressive disorder for patients that had not responded well to an existing antidepressant.

Seroquel XR has already been approved in 72 countries for schizophrenia and has also been widely approved for bipolar disorders.

The Seroquel franchise had sales of $1.35 billion (875 million pounds) in the second quarter, accounting for 16 percent of AstraZeneca's revenue, but has been subject to long-running legal claims after being linked to an increased risk of diabetes.

The Anglo-Swedish company agreed to pay $198 million to settle some 17,500 U.S. personal injury claims related to the medicine last month.

The EC decision followed a positive recommendation by the Committee for Medicinal Products for Human Use in April.

AstraZeneca said it would seek local approvals in European markets, a process that take 30 days for the 17 states in a mutual recognition procedure.

(Reporting by Paul Sandle, Editing by Mark Potter)

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