FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs / Submissions and Approvals

QRxPharma’s Moxduo Gets New PDUFA Date

Dec. 12, 2013
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The FDA has assigned QRxPharma’s Moxduo dual morphine and oxycodone opioid pain therapy a new PDUFA date of May 25, 2014, after the company refiled its NDA last month.

The new date comes after a long road that has been fraught with obstacles for Moxduo. The sponsor submitted its original NDA in 2011, but the application was met with a complete response letter in June 2012 requesting safety and efficacy clarifications. Then in August of this year, an advisory committee meeting to discuss the drug was cancelled after the FDA requested more data on blood oxygen levels in patients participating in a Phase III study, forcing the company to file yet again.

QRxPharma CEO John Holaday says he expects an advisory panel will eventually convene in April. Depending on the meeting’s outcome, the company is hoping to launch the product in the U.S. in late 2014 with help from partner Actavis. — Lena Freund

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