Daybue

Acadia Pharmaceuticals Inc.🇺🇸 United States

FDA Page

Effective Date: Sep 4, 2026
Approval ID: 67e6f2d9-21f6-466f-9def-826c6a4b8257
Products: 4 registered
Version: 12

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use DAYBUE or DAYBUE STIX safely and effectively. See full prescribing information for DAYBUE and DAYBUE STIX. DAYBUE (trofinetide) oral solution DAYBUE STIX (trofinetide) for oral solutionInitial U.S. Approval: 2023

Quick Stats

Total Products4

Labelers2

Label Sections43

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.