The FDA has approved Maxigesic IV (paracetamol/ibuprofen, Hyloris Pharmaceuticals) for the relief of mild to moderate pain and for the management of moderate to severe pain as an adjunct to opioid analgesics in adults, where an intravenous route of administration is considered clinically necessary.
The approval for the New Drug Application is based on positive data from a phase 3 program in which Maxigesic IV demonstrated that it was well tolerated and offered a faster onset of action and higher