← FDA DRUG APPROVALS

FDA NDA · NDA217785

REZDIFFRA

resmetirom

Sponsor: MADRIGAL

APPLICATION
NDA217785
TYPE
NDA
ORIGINAL APPROVAL
2024-03-14
LATEST ACTION
2026-07-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

REZDIFFRA · ReferencePrescription
RESMETIROM 60MG · TABLET · ORAL
REZDIFFRA · ReferencePrescription
RESMETIROM 80MG · TABLET · ORAL
REZDIFFRA · ReferencePrescription
RESMETIROM 100MG · TABLET · ORAL

Approval history

2026-07-24Labeling · Supplement 6 · standard — Letter ↗AP
2025-12-19Labeling · Supplement 5 · standard — Label ↗AP
2025-12-19Labeling · Supplement 4 · standard — Label ↗AP
2025-12-19Labeling · Supplement 2 · standard — Label ↗AP
2024-03-14Type 1 - New Molecular Entity · Original · priority — Label ↗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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