RecallHawk

DAYBUE (TROFINETIDE)

ACADIA PHARMS INC

Summary

FDA approved DAYBUE (TROFINETIDE) by ACADIA PHARMS INC. NDA (New Drug) approval (Efficacy) on 2026-03-27. SOLUTION, ORAL.

Details

Source

Drug Approval

External ID

NDA217026-8

Action Date

2026-03-27

Status

Approved

Category

drug

Product Code

NDA (New Drug)

Product Description

DAYBUE (generic: TROFINETIDE), SOLUTION, ORAL. Application: NDA217026

Context & Analysis

ACADIA PHARMS INC has 3 FDA actions in our database.

Frequently Asked Questions

How often does ACADIA PHARMS INC have FDA actions?

ACADIA PHARMS INC has 3 FDA actions in our database, including 0 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "NDA217026-8" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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