FDA extends timeline for NDA

RNS Number : 7223S

AstraZeneca PLC

15 September 2010

 



US Food and drug administration extends review timeline for brilinta (ticagrelor) New drug Application

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.

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

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15 September 2010

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