Prescription medicine
Dabrafenib Brand names: Tafinlar
Dabrafenib (Tafinlar) is a prescription medicine with an FDA approval on record since 2013. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the dabrafenib FDA label on DailyMed (effective May 20, 2026, Novartis Pharmaceuticals Corporation); the NDA 202806 record on Drugs@FDA; every dabrafenib label on DailyMed.
Highlights of the record
FDA label of May 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageTAFINLAR 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.
Forms and strengths
- 10 mg
- 50 mg
- 75 mg
Capsule; tablet for suspension.
On the market
- Earliest approval on file
- May 29, 2013 Tafinlar, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- February 28, 2034 Tafinlar capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 20,946 through July 30, 2026
What is dabrafenib used for?
From the label: indications and usageTAFINLAR 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. […]
Conditions named in the indications of dabrafenib's FDA labels, with every medicine labeled for each:
From other dabrafenib labelsLung cancer: … resection. ( 1.3 , 2.1 ) the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. …
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (Tafinlar), Novartis Pharmaceuticals Corporation, effective May 20, 2026 (SPL set fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea), via openFDA; the full label on DailyMed
What does the patient leaflet for dabrafenib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about TAFINLAR?TAFINLAR may cause serious side effects, including: Risk of new cancers. TAFINLAR, when used alone or with trametinib, may cause skin cancers, called cutaneous squamous cell carcinoma (cuSCC), keratoacanthoma, basal cell carcinoma, or melanoma. Talk with your healthcare provider about your risk for these cancers. Check your skin and tell your healthcare provider right away about any skin changes, including a: new wart skin sore or reddish bump that bleeds or does not heal change in size or color of a mole Your healthcare provider should check your skin before treatment with TAFINLAR, every 2 months during treatment with TAFINLAR, and for up to 6 months after you stop taking TAFINLAR to look for any new skin cancers. Your healthcare provider should also check for cancers that may not occur on the skin. Tell your healthcare provider about any new symptoms that develop during treatment with TAFINLAR. See "What are the possible side effects of TAFINLAR?" for more information about side effects.
From the patient leaflet: How should I store TAFINLAR?TAFINLAR Capsules: Store TAFINLAR capsules at room temperature between 68°F to 77°F (20°C to 25°C). Keep TAFINLAR capsules in the original bottle. The bottle of TAFINLAR capsules contains a canister with a drying agent (desiccant) to help keep your medicine dry. Do not throw away the desiccant canister. TAFINLAR tablets for oral suspension: Store the bottle of TAFINLAR tablets for oral suspension at room temperature between 68°F to 77°F (20°C to 25°C). Store the bottle of TAFINLAR tablets for oral suspension, along with the two plastic canisters inside the original packaging, with the cap tightly closed. The canisters contain a drying agent (desiccant) to help keep your medicine dry. TAFINLAR tablets for oral suspension come in a bottle with a child-resistant cap. Throw away any TAFINLAR oral suspension if it is not taken or given within 30 minutes after it is prepared. […]
Source: FDA drug label (Tafinlar), Novartis Pharmaceuticals Corporation, effective May 20, 2026 (SPL set fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea), via openFDA; the full label on DailyMed
Is there a generic for dabrafenib (Tafinlar)?
No generic dabrafenib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 6 patents for Tafinlar capsules: the compound patent runs to October 15, 2030 (pediatric exclusivity to April 15, 2031), and the last listed entry to February 28, 2034; a patent listed only for Tafinlar tablets runs to December 29, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2013 earliest approval on file
- 2034 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the dabrafenib label say about other medicines?
The dabrafenib label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name dabrafenib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Dexamethasone | drug interactions | Coadministration of TAFINLAR with other substrates of these enzymes, including dexamethasone or hormonal contraceptives, can result in decreased concentrations and loss of efficacy [see Use in Specific Populations (8.1, 8. |
| Midazolam | drug interactions | Dabrafenib decreased the systemic exposures of midazolam (a CYP3A4 substrate), S-warfarin (a CYP2C9 substrate), and R-warfarin (a CYP3A4/CYP1A2 substrate) [see Clinical Pharmacology (12.3)]. |
| Prednisone | warnings and precautions | Administer corticosteroids (e.g., prednisone 10 mg daily) for at least 5 days for second or subsequent pyrexia if temperature does not return to baseline within 3 days of onset of pyrexia, or for pyrexia associated with complications, such as dehydration, hypotension, renal failure, or severe chills/rigors, and there … |
| Trametinib | warnings and precautions | WARNINGS AND PRECAUTIONS New Primary Malignancies, Cutaneous and Non-Cutaneous: Can occur when TAFINLAR is administered as a single agent or with trametinib. |
| Warfarin | drug interactions | Monitor international normalized ratio (INR) levels more frequently in patients receiving warfarin during initiation or discontinuation of dabrafenib. |
Other labels that name dabrafenib
Source: FDA drug label (Tafinlar), Novartis Pharmaceuticals Corporation, effective May 20, 2026 (SPL set fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea), via openFDA; the full label on DailyMed
What do FAERS reports show for dabrafenib?
The FDA Adverse Event Reporting System holds 20,946 reports that list dabrafenib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,394 are coded as a death and 5,837 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as dabrafenib?
26 other medicines are given the same way (oral) and in the same FDA class as dabrafenib or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Erlotinib | Lung cancer | 10 labelers | n/a | No current entry |
| Afatinib | Lung cancer | 1 labeler | n/a | No current entry |
| Selpercatinib | Lung cancer | none listed | n/a | No current entry |
| Crizotinib | Lung cancer | none listed | n/a | No current entry |
| Gefitinib | Lung cancer | 4 labelers | n/a | No current entry |
| Brigatinib | Lung cancer | none listed | n/a | No current entry |
| Lorlatinib | Lung cancer | none listed | n/a | A presentation being discontinued |
| Trametinib | Lung cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as dabrafenib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to dabrafenib
- 26 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Dabrafenib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other