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.
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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
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