Source facts
FDA issued an approval letter for SUNLENCA on 2026-03-16. The source metadata identifies NDA 215973, NDA 215974 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
SUNLENCA — FDA Approval Letter (NDA 215973)
Issued to GILEAD SCIENCES INC. Application is approved as submitted.
Issued
March 16, 2026Application
NDA 505b1 • 215973
Product
SUNLENCA
Company
GILEAD SCIENCES INC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for SUNLENCA?
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Key details in this letter
- 1FDA action: approval.
- 2Applications: NDA 215973, NDA 215974.
- 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 SUNLENCA approval letter
Is SUNLENCA FDA approved?
This letter documents an FDA approval action: FDA approved NDA 215973 for SUNLENCA, sponsored by GILEAD SCIENCES INC, on March 16, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 215973?
NDA 215973 is the application under which FDA issued this approval letter for SUNLENCA to GILEAD SCIENCES INC. The letter is dated March 16, 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.