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FDA Sets 26 August 2013 As New PDUFA Date For MOXDUO® NDA

          FDA Sets 26 August 2013 As New PDUFA Date For MOXDUO® NDA

Product Launch Anticipated Before End of Calendar Year Pending Successful NDA
Review

PR Newswire

SYDNEY and BEDMINSTER, N.J., March 14, 2013

SYDNEY and BEDMINSTER, N.J., March 14, 2013 /PRNewswire/ --QRxPharma Limited
(ASX: QRX and OTCQX: QRXPY) announced today the US Food and Drug
Administration (FDA) has set 26 August 2013 as the Prescription Drug User Fee
Act (PDUFA) date for action on the Company'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 Officer,
QRxPharma. "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," added Holaday.

The NDA is the basis for recommencing the regulatory approval process for
MOXDUO for the treatment of moderate to severe acute pain, a $2.5 billion
segment of the $8 billion spent annually on prescription opioids in the US.
MOXDUO, an immediate release Dual Opioid^® pain therapy, is a patented 3:2
fixed ratio combination of morphine and oxycodone.

About QRxPharma
QRxPharma Limited is an Australian based, commercial-stage specialty
pharmaceutical company focused on the development and commercialisation of new
treatments for pain management. The Company's product portfolio includes both
late and early stage clinical drug candidates with the potential for reduced
risk, abbreviated development paths, and improved patient outcomes. The
Company's lead product candidate, immediate release MOXDUO^® for the treatment
of acute pain, is presently under review at the US Food and Drug
Administration. QRxPharma entered into strategic collaborations with Actavis
Inc. in December 2011 and Paladin Labs Inc. in October 2012 for the
commercialisation of immediate release MOXDUO^® in the US and Canadian acute
pain markets respectively. Additionally, the Company's clinical pipeline
includes an intravenous (IV) and continuous release (CR) formulation of
MOXDUO. For more information, visit www.qrxpharma.com.

Forward Looking Statements
This release contains forward-looking statements. Forward-looking statements
are statements that are not historical facts; they include statements about
our beliefs and expectations. Any statement in this release that states our
intentions, beliefs, expectations or predictions (and the assumptions
underlying them) is a forward-looking statement. These statements are based on
plans, estimates and projections as they are currently available to the
management of QRxPharma. Forward-looking statements therefore speak only as of
the date they are made, and we undertake no obligation to update publicly any
of them in light of new information or future events. By their very nature,
forward-looking statements involve risks and uncertainties. A number of
important factors could therefore cause actual results to differ materially
from those contained in any forward-looking statement. Such factors include
risks relating to the stage of products under development; uncertainties
relating to clinical trials; dependence on third parties; future capital
needs; and risks relating to the commercialisation of the Company's proposed
products.

SOURCE QRxPharma Limited

Website: http://www.qrxpharma.com
Contact: John W Holaday, Ph.D., Managing Director and Chief Executive Officer,
+1-301-908-3086, john.holaday@qrxpharma.com; Chris J Campbell, Chief Financial
Officer and Company Secretary, +61-2-9492-8021, chris.campbell@qrxpharma.com
 
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