Source facts
FDA issued an approval letter for LIVDELZI on 2026-02-03. The source metadata identifies NDA 217899 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
LIVDELZI — FDA Approval Letter (NDA 217899)
Issued to GILEAD SCIENCES INC. Application is approved as submitted.
Issued
February 3, 2026Application
NDA 505b1 • 217899
Product
LIVDELZI
Company
GILEAD SCIENCES INC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for LIVDELZI?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 217899.
- 3Submission: supplement.
- 4Sponsor: GILEAD SCIENCES INC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the LIVDELZI approval letter
Is LIVDELZI FDA approved?
This letter documents an FDA approval action: FDA approved NDA 217899 for LIVDELZI, sponsored by GILEAD SCIENCES INC, on February 3, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 217899?
NDA 217899 is the application under which FDA issued this approval letter for LIVDELZI to GILEAD SCIENCES INC. The letter is dated February 3, 2026.
What happens after an FDA approval letter?
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.