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| 18 May 2007 | 2007-05-18T00:00:00.0000000+01:00 |
| FDA Approves AstraZeneca’s Once-Daily SEROQUEL XR™ Extended-Release Tablets For The Treatment Of Schizophrenia
AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved SEROQUEL XR™ (quetiapine fumarate) Extended-Release Tablets, a once-daily medicine for the treatment of schizophrenia in adult patients. The SEROQUEL XR development programme was based on the needs of patients and physicians for a wider choice of medicines that offer convenient once-daily dosing. With SEROQUEL XR patients can achieve a dose within the recommended range as early as the second day of treatment. | Schizophrenia is a serious brain disorder with symptoms including distorted perceptions of reality, hallucinations and delusions, illogical thinking, and flat or blunted emotions, affecting over two million American adults – about one percent 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 of inpatients and outpatients (n=573) experiencing an acute exacerbation of symptoms 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.
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Karl Hard, Tel: +44 (0) 207 304 5322
Jörgen Winroth, Tel: +1 (212) 579 0506
Ed Seage, Tel: +1 302 886 4065
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