18th May 2007 07:01
AstraZeneca PLC18 May 2007 FDA Approves AstraZeneca's Once-Daily SEROQUEL XR(TM) Extended-Release Tablets For The Treatment Of Schizophrenia AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) hasapproved SEROQUEL XR(TM) (quetiapine fumarate) Extended-Release Tablets, aonce-daily medicine for the treatment of schizophrenia in adult patients. TheSEROQUEL XR development programme was based on the needs of patients andphysicians for a wider choice of medicines that offer convenient once-dailydosing. With SEROQUEL XR patients can achieve a dose within the recommendedrange as early as the second day of treatment. Schizophrenia is a serious brain disorder with symptoms including distortedperceptions of reality, hallucinations and delusions, illogical thinking, andflat or blunted emotions, affecting over two million American adults - about onepercent of the population age 18 and older. The FDA approval was based on a clinical trial of SEROQUEL XR at doses of 400,600, and 800 mg/day. The clinical trial was a placebo-controlled study ofinpatients and outpatients (n=573) experiencing an acute exacerbation ofsymptoms of schizophrenia. The US patent for SEROQUEL XR expires in 2017.SEROQUEL XR will be launched in the USA in the second half of 2007. -Ends- 18 May 2007 Media Enquiries:Edel McCaffrey, Tel: +44 (0) 207 304 5034Steve Brown, Tel: +44 (0) 207 304 5033 Investor Relations:Mina Blair, Tel: +44 (0) 207 304 5084Jonathan Hunt, Tel: +44 (0) 207 304 5087 Karl Hard, Tel: +44 (0) 207 304 5322Jorgen Winroth, Tel: +1 (212) 579 0506Ed Seage, Tel: +1 302 886 4065 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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