Genentech gets FDA nod for new indication for Xofluza   

The Food and Drug Administration has cleared Genentech’s Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza for patients 12 years of age and older after contact with an individual who has the flu.

Xofluza, previously available only in tablet form, is also now available as granules for mixing in water. Xofluza was originally approved in 2018 for treating uncomplicated flu in patients 12 years of age and older who have been symptomatic for no more than 48 hours.

"This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic," said Debra Birnkrant, director of the division of antiviral products in the FDA's Center for Drug Evaluation and Research. "Americans will have to be more vigilant than ever as these viruses spread concurrently."