Hyloris And Hikma Ally On Maxigesic IV In US
Firms Strike Marketing Partnership For Intravenous Paracetamol/Ibuprofen
Hyloris has secured Hikma as its US marketing partner for Maxigesic IV. The deal gives Hyloris access to Hikma’s presence in complex, injectable hospital products while aligning with Hikma’s push into differentiated treatments.
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Hyloris Submits Additional Data For Maxigesic IV Filing To US FDA
Hyloris has submitted additional data to the US Food and Drug Administration about its value-added analgesic Maxigesic IV, following enquiries about potential extractable and leachable compounds expected to be present in the product due to the packaging.
FDA Asks Hyloris For More Data On Maxigesic IV
Hyloris has received a complete response letter from the US FDA asking for more information on its 505(b)(2) hybrid application for its Maxigesic IV intravenous analgesic for treating post-operative pain.
Hyloris Gets Head Start On Maxigesic IV In US
The US FDA has set a PDUFA date for Hyloris’ Maxigesic IV 505(b)(2) NDA that is earlier than expected, following two positive Phase III trials, spurring hopes that the product could also see earlier commercialization and registration than previously anticipated.