Source facts
FDA issued an approval letter for ENNUMO on 2026-05-12. The source metadata identifies BLA 761147 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
ENNUMO — FDA Approval Letter (BLA 761147)
Issued to ACCORD BIOPHARMA INC.. Application is approved as submitted.
Issued
May 12, 2026Application
BLA • 761147
Product
ENNUMO
Company
ACCORD BIOPHARMA INC.
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for ENNUMO?
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 761147.
- 3Submission: original application.
- 4Sponsor: ACCORD BIOPHARMA INC..
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the ENNUMO approval letter
Is ENNUMO FDA approved?
This letter documents an FDA approval action: FDA approved BLA 761147 for ENNUMO, sponsored by ACCORD BIOPHARMA INC., on May 12, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is BLA 761147?
BLA 761147 is the application under which FDA issued this approval letter for ENNUMO to ACCORD BIOPHARMA INC.. The letter is dated May 12, 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.