Trials & Filings

QRxPharma Gets Action Date for MOXDUO

Pain treatment ruling scheduled for May 2014

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

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...

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