Source facts
FDA issued an approval letter for XATMEP on 2026-05-29. The source metadata identifies NDA 208400 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
XATMEP — FDA Approval Letter (NDA 208400)
Issued to AZURITY. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for XATMEP?
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 208400.
- 3Submission: supplement.
- 4Sponsor: AZURITY.
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 XATMEP approval letter
Is XATMEP FDA approved?
This letter documents an FDA approval action: FDA approved NDA 208400 for XATMEP, sponsored by AZURITY, on May 29, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 208400?
NDA 208400 is the application under which FDA issued this approval letter for XATMEP to AZURITY. The letter is dated May 29, 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.