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
BRILINTA and BRILIQUE are trademarks of the AstraZeneca group of
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
For more information about AstraZeneca in the US or the
AZ&Me™ Prescription Savings programs, please visit: www.astrazeneca