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