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# FDA Approves 1st Generic Version of Flu Drug Xofluza
- URL: https://www.fdaweb.com/fda-approves-1st-generic-version-of-flu-drug-xofluza/
- Published: 2026-06-19T12:00:00.000Z
- Updated: 2026-09-14T13:41:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161341

FDA has approved the first generic version of Genentech’s Xofluza (baloxavir marboxil), clearing Norwich Pharmaceuticals' generic tablets for the treatment and prevention of influenza in patients aged five years and older. The approval covers the drug’s administration as a single oral dose for acute uncomplicated influenza.

The labeling includes a contraindication for patients with a history of hypersensitivity reactions to baloxavir marboxil or any component of the formulation. Warnings include the potential for treatment-emergent viral resistance, particularly in younger pediatric populations. Common adverse reactions reported with the drug include diarrhea, bronchitis, nausea, sinusitis and headache, FDA says.