XOFLUZA (BALOXAVIR MARBOXIL)
Summary
FDA approved XOFLUZA (BALOXAVIR MARBOXIL) by GENENTECH INC. NDA (New Drug) approval (Efficacy) on 2025-05-30. FOR SUSPENSION, ORAL.
Details
Source
Drug Approval
External ID
NDA214410-8
Action Date
2025-05-30
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
XOFLUZA (generic: BALOXAVIR MARBOXIL), FOR SUSPENSION, ORAL. Application: NDA214410
Company
Context & Analysis
GENENTECH INC has 11 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
How often does GENENTECH INC have FDA actions?
GENENTECH INC has 11 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA214410-8" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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