US Seeks More Info on Seroquel From AstraZeneca
Fri, 02/27/2009 - 4:01am
LONDON (AP) — AstraZeneca PLC said Friday that U.S. regulators have asked for additional information about the proposed release of Seroquel XR extended release tablets for treatment of anxiety in adults. The company announced earlier this week that it would meet with the Food and Drug Administration in April to discuss the safety and effectiveness of Seroquel for treating major depressive disorder and anxiety. The Food and Drug Administration approved Seroquel in bipolar disorder in late 2008. Worldwide sales of Seroquel totaled $4.45 billion in 2008, making it AstraZeneca's second-best selling drug after the heartburn treatment Nexium.