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
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