← FDA DRUG APPROVALS

FDA NDA · NDA219884

DAYBUE STIX

trofinetide

Sponsor: ACADIA PHARMS INC

APPLICATION
NDA219884
TYPE
NDA
ORIGINAL APPROVAL
2025-12-11
LATEST ACTION
2025-12-11
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

2025-12-11Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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