MoxDuo

Type: Product

Name: MoxDuo

First reported May 19 2013 - Updated May 19 2013 - 1 reports

QRx to face FDA panel in July

The advisory panel to the US Food & Drug Administration (FDA) will meet in mid-July 2013 to review QRxPharma's resubmitted application for its painkiller MoxDuo. In July 2012, the FDA refused to accept the drug on the grounds that it combined two opiates, ... [Published Individual.com - May 19 2013]

Entities: FDA Food & Drug Administration, Stu Roberts, MoxDuo, QRxPharma Limited, Bell Potter

First reported May 17 2013 - Updated May 17 2013 - 6 reports

FDA advisory committee to meet in July on opioid painkiller

Committee to consider QRxPharma's MoxduoRelated ContentSYDNEY — A Food and Drug Administration panel will consider whether to recommend approval for an experimental painkiller in July, the drug's developer said Friday.Australia-based QRxPharma said the ... [Published Drug Store News - May 17 2013]

Entities: opioid, anodyne, FDA Food & Drug Administration, MoxDuo, QRxPharma Limited

First reported May 17 2013 - Updated May 17 2013 - 1 reports

FDA Food & Drug Administration

Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.Name of Committee: Anesthetic and Analgesic Drug Products Advisory Committee.General Function ... [Published Zecco - May 17 2013]

Entities: FDA Food & Drug Administration, Analgesic, Drugs, Silver Spring (United States)

First reported Mar 16 2013 - Updated Mar 16 2013 - 1 reports

US FDA accepts QRxPharma's Moxduo resubmitted NDA; sets August 26 as new PDUFA date

as Prescription Drug User Fee Act (PDUFA) date for action on QRxPharma's resubmitted Moxduo New Drug Application (NDA).“We are pleased that the FDA has formally accepted our resubmitted Moxduo NDA,” said Dr John Holaday, managing director and chief executive ... [Published PharmaBiz - Mar 16 2013]

Entities: MoxDuo, QRxPharma Limited, Prescription Drug User Fee Act, New Drug Application

Quotes

...is within the expected date range of late June to late July," said Dr JohnJohn Holaday, Managing Director and Chief Executive Officer, QRxPharma. "Formal notification of the Advisory Committee date finalises the sequence of events which lead to the previously announced PDUFA date of 26 August 2013" added Holaday

FDA Sets 17 July 2013 For MOXDUO?? Advisory Committee Meeting [Published BioSpace - May 17 2013]

More Content

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QRx to face FDA panel in July [Published Individual.com - May 19 2013]
QRxPharma Limited (QRX) - Pharmaceuticals & Hea... [Published TransWorldNews - May 18 2013]
FDA advisory committee to meet in July on opioi... [Published Drug Store News - May 17 2013]
FDA Sets 17 July 2013 For MOXDUO?? Advisory Com... [Published BioSpace - May 17 2013]
QRxPharma to face FDA panel in July [Published Australian Financial Review - May 17 2013]
FDA Sets 17 July 2013 For MOXDUO Advisory Commi... [Published FinanzNachrichten.de - May 17 2013]
FDA Sets 17 July 2013 For MOXDUO® Advisory Comm... [Published PR Newswire - May 17 2013]
Anesthetic and Analgesic Drug Products Advisory... [Published Zecco - May 17 2013]
FDA sets 17 July 2013 for MOXDUO Advisory Commi... [Published Noodls - May 17 2013]
QRXPHARMA LTD.: FDA sets 17 July 2013 for MOXDU... [Published 4 Traders - May 17 2013]
US FDA accepts QRxPharma's Moxduo resubmitted N... [Published PharmaBiz - Mar 16 2013]
FDA Sets 26 August 2013 As New PDUFA Date For M... [Published PR Newswire: Policy & Public Interest - Mar 14 2013]
Investment Research Weekly Roundup including Co... [Published Proactiveinvestors United Kingdom RSS feed - Mar 08 2013]
QRxPharma Resubmits MOXDUO® New Drug Applicatio... [Published PR Newswire: Health - Feb 28 2013]
QRxPharma and FDA Establish Path Forward for Re... [Published PR Newswire: Health - Jan 16 2013]