Source facts
FDA issued an approval letter for Xeomin on 2026-03-02. The source metadata identifies BLA 125360 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
Xeomin — FDA Approval Letter (BLA 125360)
Issued to MERZ PHARMS. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for Xeomin?
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: BLA 125360.
- 3Submission: supplement.
- 4Sponsor: MERZ PHARMS.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the Xeomin approval letter
Is Xeomin FDA approved?
This letter documents an FDA approval action: FDA approved BLA 125360 for Xeomin, sponsored by MERZ PHARMS, on March 2, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is BLA 125360?
BLA 125360 is the application under which FDA issued this approval letter for Xeomin to MERZ PHARMS. The letter is dated March 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.