Source facts
FDA issued an approval letter for FOUNDAYO on 2026-04-02. The source metadata identifies NDA 220934 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
FOUNDAYO — FDA Approval Letter (NDA 220934)
Issued to ELI LILLY AND CO. Application is approved as submitted.
Issued
April 2, 2026Application
NDA 505b1 • 220934
Product
FOUNDAYO
Company
ELI LILLY AND CO
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for FOUNDAYO?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 220934.
- 3Submission: original application.
- 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 FOUNDAYO approval letter
Is FOUNDAYO FDA approved?
This letter documents an FDA approval action: FDA approved NDA 220934 for FOUNDAYO, sponsored by ELI LILLY AND CO, on April 2, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 220934?
NDA 220934 is the application under which FDA issued this approval letter for FOUNDAYO to ELI LILLY AND CO. The letter is dated April 2, 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.