NDA 219389, held by Springworks. Mirdametinib.
As of Nov 14, 2026, NDA 219389 (Gomekli), held by Springworks, was first approved by FDA on Feb 11, 2025, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 11, 2025 | Original applicationNew dosage form · Priority review | Approved |
| Gomekli1MG · capsule;oral | Mirdametinib | RxReference drug |
| Gomekli2MG · capsule;oral | Mirdametinib | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
