MoxDuo
Generic name: morphine and oxycodone
Treatment for: Pain
Complete Response Letter for Moxduo NDA
QRxPharma Receives Complete Response Letter From FDA Regarding MoxDuo NDA
Sydney, Australia and Bedminster, New Jersey, June 27, 2012 – QRxPharma Limited announced today the United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the MoxDuo New Drug Application (NDA) for the treatment of moderate to severe acute pain. The Company is presently considering its response to the requests for additional information with regard to the safety and effectiveness of MoxDuo and has been granted a meeting with the FDA to clarify the steps required for approval.
“We remain confident in MoxDuo as a potential therapeutic option for the millions of patients suffering from moderate to severe acute pain and will continue our efforts to bring this therapy to market,” said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma.
"While we are disappointed by the Complete Response Letter, we are supportive of QRxPharma’s continued efforts to work with the FDA to fully address their questions in a timely manner,” said Doug Boothe, Chief Executive Officer, Actavis Inc. Within ten months of receiving a New Drug Application the FDA must provide either a decision to approve or issue a complete response, which informs the submission sponsor of changes that must be made before its application can be approved. QRxPharma has up to one year to resubmit its application from the date of notification.
Posted: June 2012
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- QRxPharma Announces 25 May 2014 as New PDUFA Date for MoxDuo NDA - December 11, 2013
- QRxPharma Refiles MoxDuo New Drug Application with the FDA - November 26, 2013
- QRxPharma Receives Complete Response Letter From FDA Regarding MoxDuo NDA - August 28, 2013
- FDA Sets 26 August 2013 As New PDUFA Date For MoxDuo NDA - March 14, 2013
- QRxPharma Resubmits MoxDuo New Drug Application to the FDA - February 28, 2013
- QRxPharma and FDA Establish Path Forward for Resubmission Of Moxduo New Drug Application - January 16, 2013
- QRxPharma Granted Target Date for FDA Action on MoxDuo IR NDA: NDA Accepted for Review; PDUFA Date Set for June 25, 2012 - November 11, 2011
- QRxPharma Completes NDA Submission for MoxDuo IR - August 26, 2011
- QRxPharma Announces NDA Filing for MoxDuo IR - July 19, 2011
MoxDuo (morphine and oxycodone) FDA Approval History
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