Roche targets children with Xofluza following 'hardest-hitting influenza' season

27 March 2020

Swiss pharma giant Roche (ROG: SIX) has announced that the US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) as well as two supplemental New Drug Applications (sNDA) for Xofluza (baloxavir marboxil).

The FDA accepted an NDA for a new formulation as one-dose granules for oral suspension (2 mg/mL), promising to offer a more convenient option for children and those who have difficulty swallowing.

'A critical need for additional options'

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