Hyloris Gets Head Start On Maxigesic IV In US
FDA Sets Earlier Than Expected PDUFA Date For Value-Added Intravenous Analgesic
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 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 expects to expand its portfolio to around 30 candidates by 2024, bolstered by €50m in cash and cash equivalents as of the end of 2021.