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Xofluza FDA Approval History

Reviewed by J.Stewart BPharm. Last updated on Oct 17, 2019.

FDA Approved: Yes (First approved October 24, 2018)
Brand name: Xofluza
Generic name: baloxavir marboxil
Dosage form: Tablets
Company: Genentech, Inc.
Treatment for: Influenza

Xofluza (baloxavir marboxil) is a polymerase acidic (PA) endonuclease inhibitor for the treatment of influenza (the flu) in people 12 years of age and older who have had flu symptoms for no more than 48 hours and who are otherwise healthy, or at high risk of developing flu-related complications.

Xofluza is taken as a single dose orally within 48 hours of onset of symptoms.

The approved recommended dosage of Xofluza is based on body weight:

  • Single dose of 40 mg for patients 40 kg to < 80 kg
  • Single dose of 80 mg for patients ≥ 80 kg

Important Safety Information

Do not take Xofluza if you are allergic to baloxavir marboxil or any of the ingredients in Xofluza.

Before you take Xofluza, tell your healthcare provider about all of your medical conditions, including if you:

  • are pregnant or plan to become pregnant. It is not known if Xofluza can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Xofluza passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Talk to your healthcare provider before you receive a live flu vaccine after taking Xofluza.

Take Xofluza with or without food. Do not take Xofluza with dairy products, calcium-fortified beverages, laxatives, antacids or oral supplements containing iron, zinc, selenium, calcium or magnesium.

The most common side effects are diarrhea, bronchitis, nausea, common cold symptoms (nasopharyngitis) and headache.

Xofluza is not effective in treating infections other than influenza. Other kinds of infections can have symptoms like those of the flu or occur along with the flu and may need different kinds of treatment. Tell your healthcare provider if you feel worse or develop new symptoms during or after treatment with Xofluza or if your flu symptoms do not start to get better.

Development Timeline for Xofluza

Oct 17, 2019Approval Genentech Announces FDA Approval of Xofluza (baloxavir marboxil) for People at High Risk of Developing Influenza-Related Complications
Oct 24, 2018Approval FDA Approves Xofluza (baloxavir marboxil) for the Treatment of Acute Uncomplicated Influenza
Jul 16, 2018Phase III CAPSTONE-2 Study Showed That Baloxavir Marboxil Reduced Symptoms in People at High Risk of Complications From the Flu
Jun 25, 2018FDA Grants Priority Review to Genentech’s Baloxavir Marboxil for the Treatment of Influenza

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.