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Xofluza FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 29, 2020.

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

Xofluza (baloxavir marboxil) is a polymerase acidic (PA) endonuclease inhibitor for the treatment of influenza, and for the post-exposure prophylaxis of influenza in people 12 years of age and older.

  • Xofluza is taken as a single dose as soon as possible (within 48 hours) of influenza symptom onset for treatment of acute uncomplicated influenza, or following contact with an individual who has influenza.
  • The approved recommended dosage of Xofluza is based on body weight for patients 12 years of age and older:
    • Less than 80 kg - Single dose of 40 mg
    • At least 80 kg - Single dose of 80 mg
  • Xofluza can be taken 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 of Xofluza include diarrhea, bronchitis, nausea, sinusitis, and headache.

Development Timeline for Xofluza

Nov 23, 2020Approval  Genentech Announces FDA Approval of Xofluza for the Prevention of Influenza Following Contact With an Infected Person
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.