FDA Sets Date for Moxduo Advisory Committee Meeting
QRxPharma Limited announced today the United States Food and Drug Administration (FDA) has set 22 April 22, 2014 as the date of the Advisory Committee meeting to consider the company's resubmitted Moxduo New Drug Application (NDA).
"As previously announced, our PDUFA date is 25 May, 2014," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. "We look forward to presenting to the Advisory Committee the Moxduo clinical data as outlined in our New Drug Application highlighting what the Company believes is Moxduo's respiratory benefit from Study 022." The Advisory Committee meeting is open to the public and will be held from 8.00am to 5.00pm at the FDA White Oak Conference Center, in Building 31, the "Great Room" (Rm. 1503), 10903 New Hampshire Avenue, Silver Spring, Maryland. The meeting will also be webcast live, the details of which will be provided by the FDA in advance of the meeting.