FDA extends PDUFA date for AstraZeneca's ticagrelor NDA

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Sep 15 2010AstraZeneca

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.

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AstraZeneca

Posted in: Medical Condition News | Pharmaceutical News

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