General MedicationsORALStandard
DAYBUE
TROFINETIDE
Standard Dose
200MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary
Approval overview DAYBUE is listed in Drugs@FDA under application 217026 (NDA).
Review priority: PRIORITY Marketing status: Prescription Active ingredient TROFINETIDE Form and strength SOLUTION;ORAL - 200MG/ML Sponsor ACADIA PHARMS INC Submission history Latest submission status date: 2026-03-27 00:00:00.
Structured Monograph
Clinical summary
Approval overview DAYBUE is listed in Drugs@FDA under application 217026 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient TROFINETIDE Form and strength SOLUTION;ORAL - 200MG/ML Sponsor ACADIA PHARMS INC Submission history Latest submission status date: 2026-03-27 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: PRIORITY
Interaction Notes
- No interaction notes stored yet.