FDA NDA · NDA219884
DAYBUE STIX
trofinetide
Sponsor: ACADIA PHARMS INC
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APPLICATION
NDA219884
TYPE
NDA
ORIGINAL APPROVAL
2025-12-11
LATEST ACTION
2026-10-16
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION, SOLUTION
MARKETING STATUS
Prescription
Products
DAYBUE STIX · ReferencePrescription
TROFINETIDE 8000MG/PACKET · FOR SOLUTION · ORAL
DAYBUE STIX · ReferencePrescription
TROFINETIDE 5000MG/PACKET · FOR SOLUTION · ORAL
DAYBUE STIXPrescription
TROFINETIDE 10,000MG · SOLUTION · ORAL
DAYBUE STIX · ReferencePrescription
TROFINETIDE 6000MG/PACKET · FOR SOLUTION · ORAL
DAYBUE STIXPrescription
TROFINETIDE 12,000MG · SOLUTION · ORAL
Approval history
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →