Hyloris Pharma wins US FDA approval for pain treatment (Yahoo Finance) - Oct 18, 2023 - "The U.S. health regulator has approved Hyloris Pharmaceuticals' drug for post-operative pain, the Belgium-based company said on Wednesday, adding that it expects to launch the non-opioid treatment in the United States by early next year. The injectable drug, branded as Maxigesic IV, was approved as a post-operative drug in hospitals or when patients cannot take medicine orally. The U.S. Food and Drug Administration's decision was based on data from a late-stage study that showed the drug to be more effective in relieving pain than commonly-used intravenous paracetamol."
NDA • CNS Disorders • Pain
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