BrilintaTreatment for Acute Coronary Syndrome, Coronary Artery Disease, Cardiovascular Risk Reduction, Ischemic Stroke, Prophylaxis
Update: Brilinta (ticagrelor) Now FDA Approved - July 20, 2011
US Food and Drug Administration Extends Review Timeline For Brilinta (Ticagrelor) New Drug Application
LONDON, 15 September 2010 - AstraZeneca today announced that the US Food and Drug Administration (FDA) has extended the time to complete its review of the New Drug Application (NDA) for ticagrelor (Brilinta).
Accordingly, the FDA extended the Prescription Drug User Fee Act (PDUFA) date from 16 September 2010 to 16 December 2010. AstraZeneca will continue to work closely with the FDA to support the review of the ticagrelor NDA.
Ticagrelor is currently under regulatory review in nine additional territories around the world, including the European Union, Canada, and Brazil.
Ticagrelor (Brilinta/Brilique) is an investigational oral antiplatelet treatment for Acute Coronary Syndromes (ACS). Ticagrelor is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclo-pentyl-triazolo-pyrimidines (CPTPs). Ticagrelor is the first reversibly-binding oral ADP receptor antagonist.
Brilinta and Brilique are trademarks of the AstraZeneca group of companies.
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
Neil McCrae +44 20 7604 8236 (24 hours)
Chris Sampson +44 20 7604 8031 (24 hours)
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Investor Enquiries UK:
Jonathan Hunt +44 20 7604 8122 mob: +44 7775 704032
Karl Hård +44 20 7604 8123 mob: +44 7789 654364
Clive Morris +44 20 7604 8124 mob: +44 7710 031012
Investor Enquiries US:
Ed Seage +1 302 886 4065 mob: +1 302 373 1361
Jorgen Winroth +1 212 579 0506 mob: +1 917 612 4043
Posted: September 2010
- Brilinta Approved in the US to Reduce the Risk of Stroke in Patients with an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack - November 6, 2020
- Brilinta Approved in the US to Reduce the Risk of a First Heart Attack or Stroke in High-Risk Patients with Coronary Artery Disease - June 1, 2020
- FDA Approves Expanded Indication for Brilinta to Include Long-Term Use in Patients with a History of Heart Attack - September 3, 2015
- FDA Approves New Crushing Option for the Administration of Brilinta - March 30, 2015
- FDA approves blood-thinning drug Brilinta to treat acute coronary syndromes - July 20, 2011
- US FDA Assigns New PDUFA Date for Brilinta (ticagrelor tablets) - February 4, 2011
- AstraZeneca Replies to the US FDA Complete Response Letter for Brilinta (Ticagrelor Tablets) - January 21, 2011
- AstraZeneca Receives Complete Response Letter From US FDA For Brilinta (ticagrelor Tablets) - December 17, 2010
- FDA Advisory Committee Recommended US FDA Approval of Brilinta (Ticagrelor) for Acute Coronary Syndromes - July 29, 2010
- AstraZeneca Submits US New Drug Application for ticagrelor (Brilinta), an Investigational Antiplatelet Agent - November 19, 2009
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