FDA — authorised 11 February 2025
- Application: NDA219379
- Marketing authorisation holder: SPRINGWORKS
- Local brand name: GOMEKLI
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
🇺🇸 MIRDAMETINIB in United States
FDA authorised MIRDAMETINIB on 11 February 2025 · 19 US adverse-event reports
Marketing authorisations
FDA — authorised 11 February 2025
- Application: NDA219389
- Marketing authorisation holder: SPRINGWORKS
- Local brand name: GOMEKLI
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
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.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 19
Most-reported reactions
- Dehydration — 3 reports (15.79%)
- Constipation — 2 reports (10.53%)
- Diarrhoea — 2 reports (10.53%)
- Malaise — 2 reports (10.53%)
- Nausea — 2 reports (10.53%)
- Product Dose Omission Issue — 2 reports (10.53%)
- Product Use Issue — 2 reports (10.53%)
- Vomiting — 2 reports (10.53%)
- Abdominal Discomfort — 1 report (5.26%)
- Acne — 1 report (5.26%)
MIRDAMETINIB 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 MIRDAMETINIB approved in United States?
Yes. FDA authorised it on 11 February 2025; FDA authorised it on 11 February 2025; FDA has authorised it.
Who is the marketing authorisation holder for MIRDAMETINIB in United States?
SPRINGWORKS holds the US marketing authorisation.