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FDA NDA · NDA217026

DAYBUE

trofinetide

Sponsor: ACADIA PHARMS INC

APPLICATION
NDA217026
TYPE
NDA
ORIGINAL APPROVAL
2023-03-10
LATEST ACTION
2026-03-27
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

DAYBUE · ReferencePrescription
TROFINETIDE 200MG/ML · SOLUTION · ORAL

Approval history

2026-03-27Efficacy · Supplement 8 · priority — Label ↗AP
2025-08-05Labeling · Supplement 7 · standard — Letter ↗AP
2025-08-05Labeling · Supplement 6 · standard — Letter ↗AP
2024-09-30Labeling · Supplement 3 · standard — Label ↗AP
2024-09-30Efficacy · Supplement 1 · standard — Label ↗AP
2023-03-10Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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