NeurogesX (NGSX) Reports FDA Committee will Review sNDA for Qutenza 8% Patch
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NeurogesX, Inc. (Nasdaq: NGSX) today confirmed that the Division of Anesthesia, Analgesia and Addiction Products (DAAAP) of the U.S. Food and Drug Administration (FDA) has scheduled an Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) meeting on February 9, 2012, to review NeurogesX' supplemental New Drug Application (sNDA) for Qutenza® (capsaicin) 8% patch for the management of neuropathic pain associated with HIV-associated peripheral neuropathy (HIV-PN).
Qutenza is currently approved in the United States for the management of neuropathic pain associated with postherpetic neuralgia (PHN).
NeurogesX announced the FDA acceptance of the sNDA filing on November 14, 2011, and noted the Agency's goal is to review and act on the sNDA by March 7, 2012 under the Prescription Drug User Fee Act IIII (PDUFA). The sNDA seeks approval for a 30-minute application of Qutenza for the treatment of neuropathic pain associated with HIV-PN. The FDA granted the sNDA a priority six month review classification. FDA Priority Review status is given to drug candidates that offer significant advances in treatment, or provide a treatment where no adequate therapy exists, and accelerates the standard review time from 10 months to six months.
Qutenza is currently approved in the United States for the management of neuropathic pain associated with postherpetic neuralgia (PHN).
NeurogesX announced the FDA acceptance of the sNDA filing on November 14, 2011, and noted the Agency's goal is to review and act on the sNDA by March 7, 2012 under the Prescription Drug User Fee Act IIII (PDUFA). The sNDA seeks approval for a 30-minute application of Qutenza for the treatment of neuropathic pain associated with HIV-PN. The FDA granted the sNDA a priority six month review classification. FDA Priority Review status is given to drug candidates that offer significant advances in treatment, or provide a treatment where no adequate therapy exists, and accelerates the standard review time from 10 months to six months.
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