FDA Extends Review Timeline for Ticagrelor New Drug Application
September 15, 2010 – The U.S. Food and Drug Administration (FDA) has extended the time to complete its review of the new drug application (NDA) for ticagrelor (Brilinta), which is the first reversible oral antiplatelet drug.
Accordingly, the FDA extended the Prescription Drug User Fee Act (PDUFA) date from Sept. 16, 2010 to Dec. 16, 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 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.
For more information: www.astrazeneca-us.com
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