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AstraZeneca Receives Complete Response Letter From US FDA For BRILINTA™ (Ticagrelor Tablets)
Date:12/16/2010

WILMINGTON, Del., Dec. 16, 2010 /PRNewswire/ -- AstraZeneca (NYSE: AZN) announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the New Drug Application (NDA) for ticagrelor (BRILINTA™).

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In the CRL, the FDA requested additional analyses of the PLATO data. The agency did not request that additional studies, including clinical studies, be conducted as a prerequisite for approval of the ticagrelor NDA.

AstraZeneca is evaluating the contents of the CRL and will respond to the agency's request for additional analyses of the PLATO data as soon as possible. The company remains confident in the NDA submission for ticagrelor and in its ability to respond to the agency's questions.

"Our highest priority is to provide the requested PLATO analyses to the FDA and progress to completion of the BRILINTA NDA review," said Martin Mackay, President, Research & Development, AstraZeneca.

NOTES TO EDITORS

About BRILINTA™ (ticagrelor tablets)

BRILINTA is an oral antiplatelet treatment for acute coronary syndromes (ACS). BRILINTA is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclopentyltriazolopyrimidines (CPTPs). BRILINTA is the first reversibly-binding oral ADP receptor antagonist.

BRILINTA is currently under regulatory review in eighteen territories around the world and was granted marketing authorization under the trade name BRILIQUE™ by the European Commission (EC) on December 6, 2010.

BRILINTA and BRILIQUE are trademarks of the AstraZeneca group of companies.

About the PLATO study

PLATO was a large (18,624 patients in 43 countries) head-to-head patient outcomes study of ticagrelor versus clopidogrel, designed to establish whet
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SOURCE AstraZeneca
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