Treats unresectable or metastatic melanoma with BRAF V600E mutation. NDA 217514, held by Novartis. Dabrafenib Mesylate.
As of Nov 13, 2026, NDA 217514 (Tafinlar), held by Novartis, was first approved by FDA on Mar 16, 2023, with 8 approved supplements and 0 published complete response letters.
TAFINLAR is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. ( 1.1, 2.1 ) TAFINLAR is indicated, in combination with trametinib, for: the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. ( 1.2, 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. ( 1.3, 2.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 7, 2025 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Mar 16, 2023 | Original applicationTYPE 4/5 · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| TafinlarEQ 10MG BASE · tablet, for suspension;oral | Dabrafenib Mesylate | RxReference drug |
| Tafinlar75MG · capsule;oral | Dabrafenib Mesylate | Rx |
| Tafinlar10MG · tablet; oral suspension | Dabrafenib Mesylate | 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 6Efficacy (new indication or use) · Standard review | Approved | |
| Jan 30, 2025 | Supplement 10Labeling · 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 applicationTYPE 4/5 · 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
