ZURICH (Reuters) - Roche has received approval from the U.S. Food and Drugs Administration for its Xofluza drug to treat influenza in children aged five years and older, the drugmaker said on Friday.
The medicine has been approved to treat acute uncomplicated influenza in otherwise healthy children who have shown symptoms for no more than 48 hours.
The FDA also approved Xofluza to prevent influenza in children aged five years and above following contact with an infected person.
The drug becomes the first single-dose oral influenza medicine approved in the United States for children in this age group, Roche said. Xofluza is already FDA-approved to treat influenza in people aged 12 and above.