Posts tagged ‘post operative pain’

DYLOJECT – PDUFA Date

October 3, 2010 is the scheduled PDUFA Date for Javelin Pharmaceuticals DYLOJECT for the management of post operative pain.  The company has been silent on any actions that may have been taking place with the FDA on this submission.  One possible source of a delay on the approval of this application could be gaining assurance that the problems that led to the withdrawal of the product in the UK earlier this year are not potential problems in the US.