FDA to review QRxPharma's resubmitted MOXDUO NDA in July 2013
Published on May 18, 2013 at 2:27 AM
QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today the US Food and Drug Administration (FDA) has set 17 July 2013 as the date of the Advisory Committee meeting to consider the Company's resubmitted MOXDUO New Drug Application (NDA).
"The timing is within the expected date range of late June to late July," said Dr. John 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.
The Advisory Committee is open to the public and will be held from 8.00am to 5.00pm at the FDA White Oak Campus, in Building 31, the "Great Room" (Rm. 1503), White Oak Conference Center, 10903 New Hampshire Avenue, Silver Spring, Maryland. The meeting will also be streamed live through a webcast details of which will be provided by the FDA in advance of the meeting.