Exanta

AstraZeneca PLC 11 October 2004 AstraZeneca Receives Action Letter from FDA for EXANTA(R) (ximelagatran) October 8, 2004 - Wilmington, DE - AstraZeneca (NYSE:AZN) announced today that the US Food and Drug Administration (FDA) did not grant approval for the investigational oral anticoagulant EXANTA(R) (ximelagatran). The company had submitted a New Drug Application (NDA) for EXANTA for the prevention of strokes in patients with atrial fibrillation, for the prevention of blood clots in patients undergoing knee-replacement surgery, and for the long-term secondary prevention of blood clots following standard treatment of a clot. Following receipt of the letter, the company is considering how to proceed further with the FDA. EXANTA has been approved by European regulatory authorities for the prevention of blood clots in patients undergoing hip- and knee-replacement surgery, and has been launched in seven European markets. AstraZeneca continues to believe in the benefit/risk profile of EXANTA and will work with European and other regulatory authorities towards further approvals. ## This press release contains forward-looking statements with respect to AstraZeneca's business. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the company's Annual Report/Form 20-F for 2003. Media Enquiries:- Steve Brown, +44 207 304 5033 Edel McCaffrey, +44 207 304 5034 Investor Enquiries: Jonathan Hunt, +44 207 304 5087 Mina Blair, +44 207 304 5084 -Ends- This information is provided by RNS The company news service from the London Stock Exchange

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AstraZeneca (AZN)
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