US Food and Drug Administration Extends Review Timeline For Brilinta (Ticagrelor) New Drug Application, Astra Zeneca
Release Date: 2010-09-15
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.
| Type: | NORMAL |
| Company: | Astra Zeneca |
| Country: | 意大利 |