1. Pink Sheet

Hat Trick For Xofluza As Canadian, Swiss & Australian Regulators Join Forces

 
• By Neena Brizmohun

Xofluza is also the first non-cancer drug to be reviewed under the Australia-Canada-Singapore-Switzerland (ACSS) Consortium’s work-sharing initiative.

Three hands fist bump
Three regulatory agencies collaborated on their review of Xofluza • Source: Shutterstock

Roche’s influenza treatment, Xofluza (baloxavir marboxil), has won marketing approval in Australia, Canada and Switzerland after becoming the first drug to be evaluated jointly by three regulatory agencies taking part in an international work-sharing program for new chemical entities (NCEs).

Xofluza is the fourth drug that has been reviewed under the Australia-Canada-Singapore-Switzerland (ACSS) Consortium’s work-sharing program since the initiative was formed in 2017

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