MoxDuoTreatment for Pain
QRxPharma Announces 25 May 2014 as New PDUFA Date for MoxDuo NDA
Sydney, Australia and Bedminster, New Jersey– December 11, 2013 -QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today that the United States Food and Drug Administration (FDA) has established 25 May 2014 as the new Prescription Drug User Fee Act (PDUFA) date for action on the Company’s refiled New Drug Application (NDA) for immediate release MoxDuo. The FDA will schedule an Advisory Committee meeting prior to this date, and assuming approval, the Company plans to launch the product in the US in the second half of 2014.
“We are pleased that the FDA has assigned a PDUFA date indicating its timetable for evaluating the revised NDA and validated data,” said Dr. John Holaday, managing director and chief executive officer, QRxPharma. “As 25 May 2014 falls on a Sunday the FDA will most likely issue the action letter on the preceding Friday being 23 May” added Holaday.
“Pending US approval, we are well prepared and poised to launch MoxDuo in the US with Actavis. Actavis’ proven track record in thelaunching and marketing of opioid products will facilitate rapid uptake and significant sales in the US and maximise value for our shareholders.”
In March 2012, QRxPharma finalised a license and option agreement with Actavis, which is a leading global specialty pharmaceutical company, for exclusive commercialisation and development rights of MoxDuo in the US. QRxPharma refiled its NDA in late November. The revised NDA is the basis for recommencing the regulatory approval for MoxDuo for the treatment of moderate to severe acute pain, a US $2.5 billion segment of the US $8 billion spent annually on prescription opioids in the US.
It also serves as the regulatory foundation for submitting MoxDuo for approval in Europe, Australia, Canada and other markets in the upcoming months. MoxDuo, an immediate release Dual Opioid® pain therapy, is a patented 3:2 fixed ratio combination of morphine and oxycodone.
Source: QRxPharma Limited
Posted: December 2013
- QRxPharma Refiles MoxDuo New Drug Application with the FDA - November 26, 2013
- QRxPharma Receives Complete Response Letter From FDA Regarding MoxDuo NDA - August 28, 2013
- FDA Sets 26 August 2013 As New PDUFA Date For MoxDuo NDA - March 14, 2013
- QRxPharma Resubmits MoxDuo New Drug Application to the FDA - February 28, 2013
- QRxPharma and FDA Establish Path Forward for Resubmission Of Moxduo New Drug Application - January 16, 2013
- QRxPharma Receives Complete Response Letter From FDA Regarding MoxDuo NDA - June 27, 2012
- QRxPharma Granted Target Date for FDA Action on MoxDuo IR NDA: NDA Accepted for Review; PDUFA Date Set for June 25, 2012 - November 11, 2011
- QRxPharma Completes NDA Submission for MoxDuo IR - August 26, 2011
- QRxPharma Announces NDA Filing for MoxDuo IR - July 19, 2011