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| 19 October 2006 | 2006-10-19T07:00:00.0000000+01:00 |
| AstraZeneca Submits EU and Canadian Regulatory Filings for Sustained Release Formulation SEROQUEL SR™ for the Treatment of Schizophrenia
AstraZeneca today announced further submissions to Regulatory Authorities for the approval of the sustained release (SR) once-daily formulation of SEROQUEL® for the treatment of patients with schizophrenia, including Canada and a Marketing Authorisation Application (MAA) in the European Union (EU) under Mutual Recognition Procedure (MRP). The submission will cover all markets in the EU where SEROQUEL® is currently approved. | This follows the NDA for SEROQUEL SR™ submitted in the US earlier this year. The clinical development programme supporting the SEROQUEL SR™ application in the EU included trials using a titration period aimed at achieving a therapeutically effective dose by the second day of treatment. Another trial studied schizophrenia relapse prevention in long-term treatment with SEROQUEL SR™. The SR formulation has patent protection to 2017.
SEROQUEL® (quetiapine fumarate) has a well-established safety and efficacy profile and to date it is estimated that over 19 million people have been treated worldwide. SEROQUEL® has been licensed for the treatment of schizophrenia since 1997 and it is available in 85 countries for the treatment of this condition. SEROQUEL® is also licensed in 73 countries for the treatment of mania associated with bipolar disorder. SEROQUEL® is the number one prescribed atypical antipsychotic in the United States, with global sales of almost $2.8 billion in 2005.
Media Enquiries:
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Jonathan Hunt, Tel: +44 (0) 207 304 5087
Ed Seage, Tel: +1 302 886 4065
Jorgen Winroth, Tel +1 (212) 579 0506
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