Source facts
FDA issued an approval letter for RETEVMO on 2026-07-15. The source metadata identifies NDA 213246, NDA 218160 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
RETEVMO — FDA Approval Letter (NDA 213246)
Issued to ELI LILLY AND CO. Application is approved as submitted.
Issued
July 15, 2026Application
NDA 505b1 • 213246
Product
RETEVMO
Company
ELI LILLY AND CO
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for RETEVMO?
Source facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
Key details in this letter
- 1FDA action: approval.
- 2Applications: NDA 213246, NDA 218160.
- 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 RETEVMO approval letter
Is RETEVMO FDA approved?
This letter documents an FDA approval action: FDA approved NDA 213246 for RETEVMO, sponsored by ELI LILLY AND CO, on July 15, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 213246?
NDA 213246 is the application under which FDA issued this approval letter for RETEVMO to ELI LILLY AND CO. The letter is dated July 15, 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.