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FDA Advisory Committee Votes Against Moxduo Approval
- QRxPharma (ASX: QRX and OTCQX: QRXPY) announced today that the United States Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee has voted to recommend against approval of Moxduo, an immediate release Dual Opioid® for the treatment of moderate to severe acute pain. The Advisory Committee found the Company did not provide sufficient evidence to warrant approval of Moxduo at this time.
QRxPharma (ASX: QRX and OTCQX: QRXPY) announced today that the United States Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee has voted to recommend against approval of Moxduo, an immediate release Dual Opioid® for the treatment of moderate to severe acute pain. The Advisory Committee found the Company did not provide sufficient evidence to warrant approval of Moxduo at this time.
“We are obviously disappointed in the outcome of today’s meeting, but remain confident in the advantages of Moxduo compared to morphine and oxycodone. This is a necessary therapy for patients with moderate to severe acute pain,” said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. “We are committed to bringing to market safer therapies for pain, such as Moxduo, and preventing opioid abuse.”
Source: QRx Pharma
Press release:
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