Quick answers
- What is Dabrafenib used for?
- The FDA-approved label (Tafinlar, Novartis Pharmaceuticals Corporation, May 20, 2026) says: “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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dabrafenib have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Dabrafenib?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Dabrafenib been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Dabrafenib?
- 1 company lists prescription products of Dabrafenib in the FDA NDC Directory, including Novartis Pharmaceuticals Corporation.
What Dabrafenib is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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. …
— FDA label: Tafinlar, Novartis Pharmaceuticals Corporation, effective May 20, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Tablet, for suspension |
|---|---|
| Route | Oral |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Tafinlar |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Novartis Pharmaceuticals Corporation3 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA202806 TAFINLAR | Novartis | May 29, 2013 | 30, latest March 26, 2026 2026: Labeling · 2025: Labeling · 2025: Labeling |
| NDA217514 TAFINLAR | Novartis | March 16, 2023 | 8, latest March 26, 2026 2026: Labeling · 2025: Labeling · 2025: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tafinlar, Novartis Pharmaceuticals Corporation, effective May 20, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →