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.

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

More from Value Added Medicines

More from Products