The PDUFA Date for Astra Zeneca‘s Brilanta is still a ways off, not until July 20, 2011 but we think it’s safe to call this one an approval. AZN has had it’s problems with this application since the original submission in 2009. Initially rejected by the FDA for a variety of problems including manufacturing issues, their latest CRL only cited a reanalysis of some of the clinical data and required a post marketing safety plan, REMS. We think that AZN has probably solved both issues with the FDA. The earlier approval this year by the European Authorities and the approval earlier this month by the Canadians probably reflects the reanalyzed data. We wouldn’t be surprised if the approval came before the PDUFA Date.
Posts tagged ‘REMS’