Treats unresectable or metastatic melanoma with BRAF V600E or V600K mutations. NDA 217513, held by Novartis. Trametinib Dimethyl Sulfoxide, Trametinib.
As of Nov 13, 2026, NDA 217513 (Mekinist), held by Novartis, was first approved by FDA on Mar 16, 2023, with 9 approved supplements and 0 published complete response letters.
MEKINIST is a kinase inhibitor indicated as a single agent for the treatment of BRAF-inhibitor treatment-naïve patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. ( 1.1, 2.1 ) MEKINIST is indicated, in combination with dabrafenib, for: the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. ( 1.1, 2.1 ) the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. ( 1.2, 2.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 7, 2025 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Mar 16, 2023 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| MekinistEQ 0.05MG BASE/ML · solution;oral | Trametinib Dimethyl Sulfoxide | RxReference drug |
| Mekinist2MG · tablet;oral | Trametinib | Rx |
| Mekinist4.7MG · solution;oral | Trametinib | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 26, 2026 | Supplement 11Labeling | Approved | |
| Apr 7, 2025 | Supplement 9Labeling · Standard review | Approved | |
| Mar 19, 2025 | Supplement 8Labeling · Standard review | Approved | |
| Mar 7, 2025 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Jan 24, 2025 | Supplement 10Labeling · Standard review | Approved | |
| Oct 1, 2024 | Supplement 7Labeling · Standard review | Approved | |
| Jul 11, 2024 | Supplement 4Labeling · Standard review | Approved | |
| Mar 29, 2024 | Supplement 3Labeling · Standard review | Approved | |
| Feb 27, 2024 | Supplement 2Labeling · Standard review | Approved | |
| Mar 16, 2023 | Original applicationNew formulation or manufacturer · Priority review | Approved |
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
