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Release issued 6th August 2002
Following a constructive meeting with the US Food and Drug Administration (FDA) to discuss the company's response to the approvable letter for Crestor (rosuvastatin calcium), AstraZeneca has undertaken to provide further information from its ongoing study programme to supplement that already submitted.
This response to the approvable letter will support the use of Crestor over the dose range of 10-40mg in the general population of patients with lipid disorders and is scheduled for submission during the first quarter 2003.
There are now more than 10,000 patients in on-going studies of Crestor and the company remains confident in the product's profile and commercial potential.
The company's guidance on earnings for 2002 remains unchanged.
If you want to find out more about the company visit AstraZeneca profile.
(10th March 2003) SUCCESSFUL OUTCOME OF THE MUTUAL RECOGNITION PROCEDURE FOR CRESTOR®; IN EUROPE
(27th February 2003) ASTRAZENECA ISSUES 2002 ANNUAL REPORT
(10th July 2002) New data confirms efficacy and suitability of Crestor in a wide-range of patient populations
(9th July 2002) AstraZeneca Completes Mutual Recognition Procedure for new Paediatric Indication for Symbicort. Turbuhaler. in the European Union.
(5th July 2002) ASTRAZENECA SECURES FIRST MARKET APPROVAL FOR IRESSA IN JAPAN