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MoxDuo FDA Approval Status

FDA Approved: No
Brand name: MoxDuo
Generic name: morphine and oxycodone
Company: QRxPharma Limited
Treatment for: Pain

MoxDuo (morphine and oxycodone) was a narcotic analgesic combination in development for the treatment of moderate to severe acute pain.

In April 2014, QRxPharma announced that the U.S. Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee voted to recommend against approval of Moxduo.

In August 2014, the Company announced that it was halting all further development work on the Moxduo portfolio of products.

Development timeline for MoxDuo

Apr 22, 2014QRxPharma Issues Statement On Moxduo Advisory Committee Meeting
Dec 11, 2013QRxPharma Announces 25 May 2014 as New PDUFA Date for MoxDuo NDA
Nov 26, 2013QRxPharma Refiles MoxDuo New Drug Application with the FDA
Aug 28, 2013QRxPharma Receives Complete Response Letter From FDA Regarding MoxDuo NDA
Mar 14, 2013FDA Sets 26 August 2013 As New PDUFA Date For MoxDuo NDA
Feb 28, 2013QRxPharma Resubmits MoxDuo New Drug Application to the FDA
Jan 16, 2013QRxPharma and FDA Establish Path Forward for Resubmission Of Moxduo New Drug Application
Jun 27, 2012QRxPharma Receives Complete Response Letter From FDA Regarding MoxDuo NDA
Nov 11, 2011QRxPharma Granted Target Date for FDA Action on MoxDuo IR NDA: NDA Accepted for Review; PDUFA Date Set for June 25, 2012
Aug 26, 2011QRxPharma Completes NDA Submission for MoxDuo IR
Jul 19, 2011QRxPharma Announces NDA Filing for MoxDuo IR

Further information

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