drugset / Press release

Advisory Committee Briefing Materials For Brilinta (Ticagrelor) NDA Available On US FDA Web Site

2010-07-26 · AstraZeneca · original astrazeneca.com ↗

Monday, 26 July 2010 The US Food and Drug Administration (FDA) today posted briefing materials in advance of 28th 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. On 19th 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). NOTES TO EDITORS: 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 7304 5045 (24 hours) Chris Sampson +44 20 7304 5130 (24 hours) Sarah Lindgreen +44 20 7304 5033 (24 hours) Abigail Baron +44 20 7304 5034 (24 hours) Investor Enquiries UK: Jonathan Hunt +44 207 304 5087 mob: +44 7775 704032 Karl Hård +44 207 304 5322 mob: +44 7789 654364 Clive Morris +44 207 304 5084 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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