US Food and Drug Administration Extends Review Timeline For BRILINTA (Ticagrelor) New Drug Application

Wednesday, 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. NOTES TO EDITORS: About BRILINTA/BRILIQUE 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. 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 . CONTACTS: Media Enquiries: Neil McCrae +44 20 7604 8236 (24 hours) Chris Sampson +44 20 7604 8031 (24 hours) Sarah Lindgreen +44 20 7604 8033 (24 hours) Abigail Baron +44 20 7604 8034 (24 hours) 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 tags Corporate and financial AstraZeneca Websites This website is intended for people seeking information on AstraZeneca's worldwide business. Our country sites can be located in the AZ Network. Veeva ID: Z4-8411 Date of next review: August 2020 Resources All resources Open Innovation Externally sponsored scientific research MedImmune US prescription assistance programmes Global clinical trials information Medicines Report a possible side effect Pearl Therapeutics Quick links Media Investor Relations Partnering Careers Sustainability Modern Slavery Statement Supplier information Social Media Facebook LinkedIn Twitter Glassdoor utility links Legal notice and Terms of Use Privacy notice Cookie policy Site map Contact us © AstraZeneca 2019 You are now leaving AstraZeneca.com You have selected a link that will take you to a site maintained by a third party who is solely responsible for its contents. AstraZeneca provides this link as a service to website visitors. AstraZeneca is not responsible for the privacy policy of any third party websites. We encourage you to read the privacy policy of every website you visit. Click ‘cancel’ to return to AstraZeneca’s site or ‘continue’ to proceed. Cancel Continue ? Important notice for users You are about to access AstraZeneca historic archive material. Any reference in these archives to AstraZeneca products or their uses may not reflect current medical knowledge and should not be used as a source of information on the present product label, efficacy data or safety data. Please refer to your approved national product label (SmPC) for current product information. I have read this warning and will not be using any of the contained product information for clinical purposes. I disagree I agree ? ?

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