FDA Briefing Materials for Br

RNS Number : 9693P

AstraZeneca PLC

27 July 2010

 



Advisory Committee Briefing Materials For BRILINTA (TICAGRELOR) NDA Available On US FDA Web Site

The US Food and Drug Administration (FDA) today posted briefing materials in advance of 28^th July 2010 Cardiovascular and Renal Drugs Advisory Committee (CRDAC) to discuss the New Drug Application (NDA) filed by AstraZeneca for its investigational oral antiplatelet ticagrelor.  The proposed trade name for ticagrelor in the US is BRILINTA, pending approval from the FDA.

The briefing materials can be found on the FDA web site: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/ucm192863.htm

On 19^th November 2009, AstraZeneca announced it had submitted an NDA to the FDA for ticagrelor, for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS).

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines.  As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009.  For more information please visit: www.astrazeneca.com

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27 July 2010

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