Source facts
FDA issued an approval letter for DAYBUE on 2026-03-31. The source metadata identifies NDA 217026 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
DAYBUE — FDA Approval Letter (NDA 217026)
Issued to ACADIA PHARMS INC. Application is approved as submitted.
Issued
March 31, 2026Application
NDA 505b1 • 217026
Product
DAYBUE
Company
ACADIA PHARMS INC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for DAYBUE?
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 217026.
- 3Submission: supplement.
- 4Sponsor: ACADIA PHARMS INC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the DAYBUE approval letter
Is DAYBUE FDA approved?
This letter documents an FDA approval action: FDA approved NDA 217026 for DAYBUE, sponsored by ACADIA PHARMS INC, on March 31, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 217026?
NDA 217026 is the application under which FDA issued this approval letter for DAYBUE to ACADIA PHARMS INC. The letter is dated March 31, 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.