QRxPharma Limited
(ASX:QRX) has hit a hurdle in its efforts to bring the MoxDuo therapy to market in the United States.
The United States Food and Drug Administration has asked the pharmaceutical company to provide more information about the safety and effectiveness of its product.
QRxPharma says it is considering its response and remains confident in MoxDuo as a potential therapeutic option for the treatment of moderate to severe acute pain.
QRxPharma has a strategic partnership with Actavis Inc. to commercialise the product if approved in the US market.
The company has up to one year to resubmit its application from the date of notification.
In the first half of the 2012 financial year QRxPharma booked a net loss of $5.7 million.
