← FDA DRUG APPROVALS

FDA NDA · NDA204114

MEKINIST

trametinib

Sponsor: NOVARTIS

APPLICATION
NDA204114
TYPE
NDA
ORIGINAL APPROVAL
2013-05-29
LATEST ACTION
2026-05-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

MEKINIST · ReferencePrescription
TRAMETINIB DIMETHYL SULFOXIDE EQ 2MG · TABLET · ORAL
MEKINIST · ReferencePrescription
TRAMETINIB DIMETHYL SULFOXIDE EQ 0.5MG · TABLET · ORAL
MEKINIST · ReferenceDiscontinued
TRAMETINIB DIMETHYL SULFOXIDE EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2026-05-07Labeling · Supplement 42 · standard — Letter ↗AP
2026-03-26Labeling · Supplement 40 · standard — Label ↗AP
2025-04-21Labeling · Supplement 39 · standard — Letter ↗AP
2025-04-07Labeling · Supplement 38 · standard — Label ↗AP
2025-03-19Labeling · Supplement 37 · standard — Letter ↗AP
2025-03-07Efficacy · Supplement 34 · standard — Letter ↗AP
2025-01-24Labeling · Supplement 36 · standard — Letter ↗AP
2024-10-01Labeling · Supplement 27 · standard — Letter ↗AP
2024-07-11Labeling · Supplement 33 · standard — Letter ↗AP
2024-03-29Labeling · Supplement 32 · standard — Label ↗AP
2024-02-27Labeling · Supplement 31 · standard — Label ↗AP
2023-08-31Efficacy · Supplement 29 · priority — Letter ↗AP
2023-05-26Labeling · Supplement 28 · standard — Label ↗AP
2023-03-16Efficacy · Supplement 25 · priority — Label ↗AP
2022-06-22Efficacy · Supplement 24 · priority — Label ↗AP
2022-05-27Efficacy · Supplement 23 · standard — Letter ↗AP
2022-01-28Efficacy · Supplement 19 · standard — Letter ↗AP
2022-01-28Labeling · Supplement 21 · standard — Letter ↗AP
2021-12-03Labeling · Supplement 20 · standard — Label ↗AP
2021-05-07Labeling · Supplement 18 · standard — Letter ↗AP
2020-06-23Labeling · Supplement 16 · standard — Label ↗AP
2020-04-09Labeling · Supplement 14 · standard — Letter ↗AP
2019-10-06Efficacy · Supplement 12 · standard — Label ↗AP
2019-07-16Labeling · Supplement 13 · standard — Letter ↗AP
2018-05-04Efficacy · Supplement 9 · priority — Label ↗AP
2018-04-30Efficacy · Supplement 7 · priority — Label ↗AP
2018-03-09Labeling · Supplement 8 · standard — Label ↗AP
2017-06-22Efficacy · Supplement 5 · priority — Label ↗AP
2017-02-24Labeling · Supplement 6 · standard — Label ↗AP
2015-11-20Efficacy · Supplement 4 · priority — Label ↗AP
2014-09-26Manufacturing (CMC) · Supplement 3 · standardAP
2014-08-13Manufacturing (CMC) · Supplement 2 · standardAP
2014-01-08Efficacy · Supplement 1 · priority — Label ↗AP
2013-05-29Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →