QRxPharma Gets Action Date for MOXDUO

QRxPharma has received a Prescription Drug User Fee Act (PDUFA) action date from the FDA for immediate release MOXDUO. The agency will rule on the application by May 25, 2014.

The FDA will schedule an Advisory Committee meeting prior to this date, and if the drug is approved, the company plans to launch the product in the U.S. in 2H14 with partner Actavis. In March 2012, QRxPharma finalized a license and option agreement with Actavis, exclusive commercialization 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. 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.