General MedicationsORALGeneric

XOFLUZA

BALOXAVIR MARBOXIL

Standard Dose

20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview XOFLUZA is listed in Drugs@FDA under application 210854 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient BALOXAVIR MARBOXIL Form and strength TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor GENENTECH INC Submission history Latest submission status date: 2025-05-30 00:00:00.

Structured Monograph

Clinical summary

Approval overview XOFLUZA is listed in Drugs@FDA under application 210854 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient BALOXAVIR MARBOXIL Form and strength TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor GENENTECH INC Submission history Latest submission status date: 2025-05-30 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.