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FDA Greenlights First Generic Single-Dose Flu Medicine

18 Jun

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Summary

First generic version of Roche's single-dose flu medicine approved.
The drug treats uncomplicated flu in patients within 48 hours of symptom onset.
It is also used for flu prevention after exposure to an infected person.

FDA Greenlights First Generic Single-Dose Flu Medicine

The U.S. Food and Drug Administration has approved the first generic version of Roche's single-dose flu medication, baloxavir marboxil. This approval comes ahead of the upcoming flu season, offering a new treatment option.

The generic drug is indicated for treating uncomplicated influenza in patients aged five and older who have exhibited symptoms for 48 hours or less. It is suitable for individuals who are otherwise healthy and those at high risk of developing serious flu-related complications.

Furthermore, this medication can be administered to help prevent influenza following contact with an infected individual. Roche's original Xofluza was first authorized by the FDA in 2018 and is marketed by its Genentech unit.

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