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 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.
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.
Belgian value-added medicines specialist Hyloris Pharmaceuticals has renegotiated its licensing agreement with Alter Pharma group, wrapping up all previous agreements. Under the new agreement, Hyloris will forego all past commitments and all further future royalty obligations to Alter for Maxigesic IV.