Treats unresectable or metastatic melanoma with BRAF V600E or V600K mutations. NDA 204114, held by Novartis. Trametinib Dimethyl Sulfoxide.
As of Nov 14, 2026, NDA 204114 (Mekinist), held by Novartis, was first approved by FDA on May 29, 2013, with 33 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.
| Mar 7, 2025 | Supplement 34Efficacy (new indication or use) · Standard review | Approved | |
| Aug 31, 2023 | Supplement 29Efficacy (new indication or use) · Priority review | Approved | |
| Mar 16, 2023 | Supplement 25Efficacy (new indication or use) · Priority review | Approved | |
| Jun 22, 2022 | Supplement 24Efficacy (new indication or use) · Priority review | Approved | |
| May 27, 2022 | Supplement 23Efficacy (new indication or use) · Standard review | Approved | |
| Jan 28, 2022 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Oct 6, 2019 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| May 4, 2018 | Supplement 9Efficacy (new indication or use) · Priority review | Approved | |
| Apr 30, 2018 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Jun 22, 2017 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Nov 20, 2015 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Jan 8, 2014 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| May 29, 2013 | Original applicationNew molecular entity · Standard review | Approved |
| MekinistEQ 0.5MG · tablet;oral | Trametinib Dimethyl Sulfoxide | RxReference drug |
| MekinistEQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Trametinib Dimethyl Sulfoxide | DiscontinuedReference drug |
| MekinistEQ 2MG · tablet;oral | Trametinib Dimethyl Sulfoxide | RxReference drug |
| May 7, 2026 | Supplement 42Labeling · Standard review | Approved | |
| Mar 26, 2026 | Supplement 40Labeling · Standard review | Approved | |
| Apr 21, 2025 | Supplement 39Labeling · Standard review | Approved | |
| Apr 7, 2025 | Supplement 38Labeling · Standard review | Approved | |
| Mar 19, 2025 | Supplement 37Labeling · Standard review | Approved | |
| Mar 7, 2025 | Supplement 34Efficacy (new indication or use) · Standard review | Approved | |
| Jan 24, 2025 | Supplement 36Labeling · Standard review | Approved | |
| Oct 1, 2024 | Supplement 27Labeling · Standard review | Approved | |
| Jul 11, 2024 | Supplement 33Labeling · Standard review | Approved | |
| Mar 29, 2024 | Supplement 32Labeling · Standard review | Approved | |
| Feb 27, 2024 | Supplement 31Labeling · Standard review | Approved | |
| Aug 31, 2023 | Supplement 29Efficacy (new indication or use) · Priority review | Approved | |
| May 26, 2023 | Supplement 28Labeling · Standard review | Approved | |
| Mar 16, 2023 | Supplement 25Efficacy (new indication or use) · Priority review | Approved | |
| Jun 22, 2022 | Supplement 24Efficacy (new indication or use) · Priority review | Approved | |
| May 27, 2022 | Supplement 23Efficacy (new indication or use) · Standard review | Approved | |
| Jan 28, 2022 | Supplement 21Labeling · Standard review | Approved | |
| Jan 28, 2022 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Dec 3, 2021 | Supplement 20Labeling · Standard review | Approved | |
| May 7, 2021 | Supplement 18Labeling · Standard review | Approved | |
| Jun 23, 2020 | Supplement 16Labeling · Standard review | Approved | |
| Apr 9, 2020 | Supplement 14Labeling · Standard review | Approved | |
| Oct 6, 2019 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Jul 16, 2019 | Supplement 13Labeling · Standard review | Approved | |
| May 4, 2018 | Supplement 9Efficacy (new indication or use) · Priority review | Approved | |
| Apr 30, 2018 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Mar 9, 2018 | Supplement 8Labeling · Standard review | Approved | |
| Jun 22, 2017 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Feb 24, 2017 | Supplement 6Labeling · Standard review | Approved | |
| Nov 20, 2015 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Sep 26, 2014 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Aug 13, 2014 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jan 8, 2014 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| May 29, 2013 | Original applicationNew molecular entity · Standard 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
