FDA Asks Hyloris For More Data On Maxigesic IV
Value Added Medicines Specialist Receives Complete Response Letter From US Agency
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.
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Value-added medicines firm Hyloris has raised €15m from new and existing investors through a private equity offering of nearly one million new shares.
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.
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.