Source facts
FDA issued an approval letter for SABRIL on 2026-03-20. The source metadata identifies NDA 020427, NDA 022006 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
SABRIL — FDA Approval Letter (NDA 020427)
Issued to LUNDBECK PHARMS LLC. Application is approved as submitted.
Issued
March 20, 2026Application
NDA 505b1 • 020427
Product
SABRIL
Company
LUNDBECK PHARMS LLC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for SABRIL?
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 020427, NDA 022006.
- 3Submission: supplement.
- 4Sponsor: LUNDBECK PHARMS LLC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the SABRIL approval letter
Is SABRIL FDA approved?
This letter documents an FDA approval action: FDA approved NDA 020427 for SABRIL, sponsored by LUNDBECK PHARMS LLC, on March 20, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 020427?
NDA 020427 is the application under which FDA issued this approval letter for SABRIL to LUNDBECK PHARMS LLC. The letter is dated March 20, 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.