Source facts
FDA issued an approval letter for ZEPBOUND (AUTOINJECTOR), ZEPBOUND, ZEPBOUND KWIKPEN on 2026-02-27. The source metadata identifies NDA 217806 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
ZEPBOUND (AUTOINJECTOR) / ZEPBOUND / ZEPBOUND KWIKPEN — FDA Approval Letter (NDA 217806)
Issued to ELI LILLY AND CO. Application is approved as submitted.
Issued
February 27, 2026Application
NDA 505b1 • 217806
Product
ZEPBOUND (AUTOINJECTOR) / ZEPBOUND / ZEPBOUND KWIKPEN
Company
ELI LILLY AND CO
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for ZEPBOUND (AUTOINJECTOR) / ZEPBOUND / ZEPBOUND KWIKPEN?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 217806.
- 3Submission: supplement.
- 4Sponsor: ELI LILLY AND CO.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the ZEPBOUND (AUTOINJECTOR) / ZEPBOUND / ZEPBOUND KWIKPEN approval letter
Is ZEPBOUND (AUTOINJECTOR) / ZEPBOUND / ZEPBOUND KWIKPEN FDA approved?
This letter documents an FDA approval action: FDA approved NDA 217806 for ZEPBOUND (AUTOINJECTOR) / ZEPBOUND / ZEPBOUND KWIKPEN, sponsored by ELI LILLY AND CO, on February 27, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 217806?
NDA 217806 is the application under which FDA issued this approval letter for ZEPBOUND (AUTOINJECTOR) / ZEPBOUND / ZEPBOUND KWIKPEN to ELI LILLY AND CO. The letter is dated February 27, 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.