The US Food and Drug Administration (FDA) has set August 26, 2013 as Prescription Drug User Fee Act (PDUFA) date for action on QRxPharma's resubmitted Moxduo New Drug Application (NDA).
“We are pleased that the FDA has formally accepted our resubmitted Moxduo NDA,” said Dr John Holaday, managing director and chief executive officer, QRxPharma. “We expect the Advisory Committee meeting to be scheduled between late June and late July and will update shareholders once formal notification has been received,” added Holaday.
The NDA is the basis for recommencing the regulatory approval process for Moxduo for the treatment of moderate to severe acute pain, a $2.5 billion segment of the $8 billion spent annually on prescription opioids in the US. Moxduo, an immediate release Dual Opioid pain therapy, is a patented 3:2 fixed ratio combination of morphine and oxycodone.
QRxPharma Limited is a commercial-stage specialty pharmaceutical company focused on the development and commercialisation of new treatments for pain management.