June 17 (Reuters) – The U.S. Food and Drug Administration approved the first generic version of Roche’s Xofluza, a single-dose flu medicine for certain patients aged five years and older, the regulator said on Wednesday.
The approval of Norwich Pharmaceuticals’ generic drug comes ahead of the flu season.
It can be used to treat uncomplicated flu in patients who have had symptoms for no more than 48 hours, including those who are otherwise healthy or at high risk of flu-related complications, the FDA said.
The drug can also be used to help prevent flu after contact with an infected person, the agency added.
Baloxavir marboxil, marketed as Xofluza by Roche, was first approved by the FDA in 2018 and is taken as a single oral dose. It is marketed in the U.S. by trhe company’s Genentech unit.
The most common side effects of baloxavir marboxil include diarrhea, bronchitis, nausea, sinusitis and headache. It carries warnings such as increased incidence of treatment-emergent resistance in patients less than five years of age.
(Reporting by Kunal Das in Bengaluru; Editing by Joyjeet Das)