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# Mekinist Not Withdrawn Due to Safety/Efficacy
- URL: https://www.fdaweb.com/mekinist-not-withdrawn-due-to-safety-efficacy/
- Published: 2023-10-12T12:00:00.000Z
- Updated: 2026-09-14T19:02:17.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155549

*Federal Register* notice: FDA has determined that Novartis Pharmaceuticals’ Mekinist (trametinib dimethyl sulfoxide) tablets (1 mg) were not withdrawn for safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are met. Mekinist is a kinase inhibitor indicated as a single agent for the treating certain patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-10-12/pdf/2023-22464.pdf?ref=fdaweb.com).