Source facts
FDA issued an approval letter for IMCIVREE on 2026-03-23. The source metadata identifies NDA 213793 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
IMCIVREE — FDA Approval Letter (NDA 213793)
Issued to RHYTHM. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for IMCIVREE?
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.
- 2Application: NDA 213793.
- 3Submission: supplement.
- 4Sponsor: RHYTHM.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
Open the document workspaceFDA source document
Read the full FDA approval letter (PDF)
Loading document viewer…
Common questions about the IMCIVREE approval letter
Is IMCIVREE FDA approved?
This letter documents an FDA approval action: FDA approved NDA 213793 for IMCIVREE, sponsored by RHYTHM, on March 23, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 213793?
NDA 213793 is the application under which FDA issued this approval letter for IMCIVREE to RHYTHM. The letter is dated March 23, 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.