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.