AstraZeneca Drug Wins Partial US Approval
From Associated Press (December 4, 2009)
LONDON--Pharmaceutical company AstraZeneca PLC said Friday it has won U.S. approval for use of its schizophrenia drug Seroquel XR as an add-on treament for major depressive disorder.
But the London-based company said that the U.S. Food and Drug Administration has asked for more information before allowing the drug’s use as a single agent to treat major depressive disorder, or MDD.
Seroquel XR is an extended-release version of AstraZeneca’s schizophrenia medication Seroquel, a major seller for the company. It is already approved for bipolar disorder and schizophrenia.
AstraZeneca said it is evaluating the FDA’s request.
"AstraZeneca will continue discussions with the FDA and will provide a response to the agency in due course," it said in a statement.
The statement comes a day after AstraZeneca announced a deal to develop a depression drug with Targacept Inc. AstraZeneca is paying Targacept $200 million upfront upon effectiveness of TC-5214, Targacept’s late-stage investigational treatment for MDD.
AstraZeneca shares were up 1.1 percent at 2,802 pence ($46.64) in midday trade in London.
Posted: December 2009