FDA approved the original new drug application for MEKTOVI on June 27, 2018, sponsored by ARRAY BIOPHARMA INC. FDA classed that submission a new molecular entity, which makes it the first approval of binimetinib in any product. FDA has approved 4 efficacy supplements on the application since, the most recent on March 12, 2025.
- Application
- NDA210498
- Sponsor
- ARRAY BIOPHARMA INC
- Original approval
- Review
- standard review
- Submission class
- Type 1 - New Molecular Entity
- Active ingredient
- binimetinib
Browse every approval whose brand starts with M, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| binimetinib 15MG | TABLET | ORAL | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
| Approved | Supplement | Review |
|---|---|---|
| S-1 | standard | |
| S-9 | standard | |
| S-10 | standard | |
| S-11 | standard |
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
Other approvals to ARRAY BIOPHARMA INC
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