US FDA assigns new PDUFA date for BRILINTA (ticagrelor tablets)

AstraZeneca announced today that the US Food and Drug Administration (FDA) has acknowledged receipt of the company’s reply to the Complete Response Letter (CRL) for the ticagrelor New Drug Application (NDA). Accordingly, the agency has accepted AstraZeneca’s resubmission of the ticagrelor NDA, categorised it as a Class 2 resubmission to the CRL, and set a new PDUFA date of 20 July 2011.

The FDA issued the CRL on 16 December 2010. On 21 January 2011, AstraZeneca announced it had submitted the requested supplementary analyses as part of its CRL response.

AstraZeneca remains confident in the NDA submission for ticagrelor and will continue working with the FDA to progress towards completing the review of the NDA for ticagrelor.