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Re: DewDiligence post# 77711

Thursday, 11/19/2009 7:30:34 AM

Thursday, November 19, 2009 7:30:34 AM

Post# of 257257
AstraZeneca Files Brilinta New Drug Application With FDA:

http://online.wsj.com/article/BT-CO-20091119-701542.html

LONDON (Dow Jones)--AstraZeneca PLC, the International healthcare business, said Thursday it has submitted a new drug application, or NDA, to the U.S. Food and Drug Administration for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome.

MAIN FACTS:

-The proposed trade name for ticagrelor is Brilinta, pending approval from the FDA.

-Submission is based on the results of a comprehensive programme, including data from PLATO--a study of platelet inhibition and patient outcomes--, the Phase III head-to-head trial comparing ticagrelor plus aspirin with clopidogrel, or Plavix, plus aspirin.

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