🇺🇸 RESMETIROM in United States

FDA authorised RESMETIROM on 14 March 2024 · 12 US adverse-event reports

Marketing authorisation

FDA — authorised 14 March 2024

  • Application: NDA217785
  • Marketing authorisation holder: MADRIGAL
  • Local brand name: REZDIFFRA
  • Indication: TABLET — ORAL
  • Status: approved

The FDA approved RESMETIROM for its approved indication. The marketing authorization was granted to MADRIGAL, the marketing authorisation holder, through a standard expedited pathway. The application number for this approval is NDA217785.

Read official source →

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Alanine Aminotransferase Increased — 2 reports (16.67%)
  2. Aspartate Aminotransferase Increased — 2 reports (16.67%)
  3. Dizziness — 1 report (8.33%)
  4. Dry Skin — 1 report (8.33%)
  5. Faeces Discoloured — 1 report (8.33%)
  6. Joint Swelling — 1 report (8.33%)
  7. Peripheral Swelling — 1 report (8.33%)
  8. Pruritus — 1 report (8.33%)
  9. Rash — 1 report (8.33%)
  10. Sensitive Skin — 1 report (8.33%)

Source database →

RESMETIROM in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is RESMETIROM approved in United States?

Yes. FDA authorised it on 14 March 2024.

Who is the marketing authorisation holder for RESMETIROM in United States?

MADRIGAL holds the US marketing authorisation.