Source facts
FDA issued an approval letter for OLUMIANT on 2026-07-02. The source metadata identifies NDA 207924 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
OLUMIANT — FDA Approval Letter (NDA 207924)
Issued to ELI LILLY AND CO. Application is approved as submitted.
Issued
July 2, 2026Application
NDA 505b1 • 207924
Product
OLUMIANT
Company
ELI LILLY AND CO
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for OLUMIANT?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 207924.
- 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 OLUMIANT approval letter
Is OLUMIANT FDA approved?
This letter documents an FDA approval action: FDA approved NDA 207924 for OLUMIANT, sponsored by ELI LILLY AND CO, on July 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 207924?
NDA 207924 is the application under which FDA issued this approval letter for OLUMIANT to ELI LILLY AND CO. The letter is dated July 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.