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FDA NDA · NDA219209

JOURNAVX

suzetrigine

Sponsor: VERTEX PHARMS INC

APPLICATION
NDA219209
TYPE
NDA
ORIGINAL APPROVAL
2025-01-30
LATEST ACTION
2026-01-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

JOURNAVX · ReferencePrescription
SUZETRIGINE 50MG · TABLET · ORAL

Approval history

2026-01-23Labeling · Supplement 9 · standardLetterAP
2025-01-30Type 1 - New Molecular Entity · Original · priorityLabelAP
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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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