← FDA DRUG APPROVALS

FDA NDA · NDA210854

XOFLUZA

baloxavir marboxil

Sponsor: GENENTECH INC

APPLICATION
NDA210854
TYPE
NDA
ORIGINAL APPROVAL
2018-10-24
LATEST ACTION
2025-05-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

XOFLUZA · ReferencePrescription
BALOXAVIR MARBOXIL 40MG · TABLET · ORAL
XOFLUZA · ReferencePrescription
BALOXAVIR MARBOXIL 80MG · TABLET · ORAL
XOFLUZA · ReferenceDiscontinued
BALOXAVIR MARBOXIL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2025-05-30Efficacy · Supplement 23 · standard — Letter ↗AP
2025-01-29Manufacturing (CMC) · Supplement 24 · standard — Label ↗AP
2024-12-19Efficacy · Supplement 21 · standard — Letter ↗AP
2024-03-01Efficacy · Supplement 20 · standard — Label ↗AP
2023-06-15Labeling · Supplement 18 · standard — Label ↗AP
2022-08-11Efficacy · Supplement 9 · standard — Letter ↗AP
2022-08-11Efficacy · Supplement 5 · standard — Letter ↗AP
2021-03-18Manufacturing (CMC) · Supplement 8 · standardAP
2020-11-23Efficacy · Supplement 10 · standard — Label ↗AP
2020-11-23Efficacy · Supplement 4 · standard — Label ↗AP
2019-10-16Efficacy · Supplement 1 · standard — Letter ↗AP
2018-10-24Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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