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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

 
• By Chloe Kent

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.

June 2022 calendar
Hyloris has been granted a June 2022 PDUFA date • Source: Alamy

Belgian value-added medicines specialist Hyloris has announced that the US Food and Drug Administration has set an earlier than expected prescription drug user fee act date of 30 June 2022 for the firm’s 505(b)(2) new drug application for its Maxigesic IV (paracetamol/ibuprofen) 1,000mg/300mg intravenous analgesic for treating post-operative pain.

The 30 June 2022 date was “ahead of the August to September 2022 timeframe initially expected,” Hyloris indicated

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