Hyloris announces submission of Maxigesic IV packaging data requested by the US FDA (GlobeNewswire) - Apr 18, 2023 - "Hyloris Pharmaceuticals SA...announces that its partner AFT Pharmaceuticals ('AFT') has submitted a response to the Food & Drug Administration (FDA). The US regulatory body had requested this additional data while considering market approval for Maxigesic® IV, a novel, dual mode-of-action non-opioid pain treatment delivered through intravenous (IV) infusion....The formal response to the Complete Response Letter was filed with the FDA on 17 April 2023. Assuming a positive assessment by the FDA, this implies potential registration of Maxigesic® IV for the US market before year end."
FDA event • CNS Disorders • Pain
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