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Hyloris Gets Head Start On Maxigesic IV In US

FDA Sets Earlier Than Expected PDUFA Date For Value-Added Intravenous Analgesic

Executive Summary

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.

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Hyloris Prepares For UK And Ireland Maxigesic IV Launch

Value-added medicines specialist Hyloris has announced launch plans for its Maxigesic IV analgesic in the UK and Ireland after receiving approvals for the intravenous paracetamol/ibuprofen solution. The nods follow two deals aimed at bolstering the firm’s pipeline.

Hyloris Rolls Out Maxigesic IV In Europe

Hyloris has launched its Maxigesic IV value-added medicine in Germany and Austria, taking to five its total number of commercialized markets for the non-opioid intravenous analgesic.

Hyloris And Hikma Ally On Maxigesic IV In US

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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