Roche announces FDA approval of Xofluza for the prevention of influenza following contact with an infected person

Xofluza is the first single-dose influenza medicine approved to prevent influenza for those who have had contact with an infected person (post-exposure prophylaxis)Roche also provides an update on the sNDA filing for Xofluza in the paediatric setting
Basel, 24 November 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza® (baloxavir marboxil) as a treatment to prevent influenza in people 12 years of age and older following contact with someone with influenza (known as post-exposure prophylaxis). Xofluza is the first single-dose influenza medicine approved for post-exposure prophylaxis.
Attachment24112020_MR_ Xofluza US approval_ EN