U.S. Food and Drug Administration Extends Review Timeline for BRILINTA (Ticagrelor) New Drug Application
WILMINGTON, Del., Sept. 15 /PRNewswire/ -- AstraZeneca (NYSE: AZN) today announced that 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).
Accordingly, the FDA extended the Prescription Drug User Fee Act (PDUFA) date from September 16, 2010 to December 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.
NOTES TO EDITORS:
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 commercialization 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. In the United States, AstraZeneca is a $14.8 billion dollar healthcare business.
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