FDA to review experimental opioid drug

Agency to decide whether to approve Moxduo by Aug. 26

BEDMINSTER, N.J. — The Food and Drug Administration will decide in late August whether to approve an experimental opioid painkiller made by QRxPharma, the drug maker said Thursday.

Australia-based QRxPharma is seeking approval for Moxduo (morphine and oxycodone), and the FDA plans to decide whether to approve the drug on Aug. 26.

"We are pleased that the FDA has formally accepted our resubmitted Moxduo [new drug application]," QRxPharma CEO and managing director John Holaday said. "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."

 

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