Clinical & Regulatory Milestones

  • On 14 August 2014 the Company announced that it is halting all further development work on the Moxduo portfolio of products: August 2014
  • QRxPharma and FDA have End-of-Review meeting: July 2014
  • QRxPharma receives Complete Response Letter from the FDA: May 2014
  • Advisory Committee panel recommends against approval of Moxduo IR: April 2014
  • QRxPharma announces the date of 22 April 2014 as the Advisory Committee date: March 2014
  • The Company announces 25 May 2014 as new PDUFA date for Moxduo IR: December 2013
  • The Company refiles the NDA for Moxduo IR: November 2013
  • QRxPharma meets with FDA to discuss the NDA refiling of Moxduo and was given clear direction of the requirements for submission of the revised NDA and data validation documentation: October 2013
  • QRxPharma anticipates a new PDUFA date in Q2 2014, preceded by an Advisory Committee meeting: August 2013
  • FDA issues QRxPharma a Complete Response Letter regarding the Company’s Moxduo NDA to allow time to submit and evaluate further information required for the FDA to fully consider the respiratory safety advantages of Moxduo from Study 022: August 2013
  • QRxPharma Updates Moxduo NDA Review - New Information to Delay Planned FDA Advisory Committee Meeting and PDUFA date: June 2013
  • Submit additional regulatory filings in Europe, Australia and Canada: 2013
  • New PDUFA date of 26 August for Moxduo from the US FDA: March 2013
  • Expected review of NDA by Advisory Committee: Late Q2 2013
  • Submission of additional data package requested by FDA; re-filing of Moxduo NDA: February 2013
  • FDA review meeting of Moxduo IR: August 2012
  • PDUFA date of 25 June for Moxduo from the US FDA; CRL received: June 2012
  • QRxPharma granted additional composition of matter US Patent on immediate release Moxduo providing coverage until 2023; Files additional patents for controlled release formulation: May 2012
  • PDUFA target date for FDA action on Moxduo NDA granted: November 2011