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News Breaks
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February 9, 2012
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| 17:35 EDT |  | NGSX |
| theflyonthewall.com: | NeurogesX announces AADPAC did not recommend approval for Qutenza | | NeurogesX announced that the Anesthetic and Analgesic Drug Products Advisory Committee, or AADPAC, FDA did not recommend FDA approval of a new indication for Qutenza, or Capsaicin, 8% patch for the management of neuropathic pain related to HIV associated peripheral neuropathy. While the FDA will consider recommendations of the Committee, the decision regarding the approval of a new indication is determined by the FDA. Currently, the Company's supplemental new drug application remains under evaluation, with Priority Review status granted by the FDA. :theflyonthewall.com |
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