← FDA DRUG APPROVALS

FDA NDA · NDA202806

TAFINLAR

dabrafenib

Sponsor: NOVARTIS

APPLICATION
NDA202806
TYPE
NDA
ORIGINAL APPROVAL
2013-05-29
LATEST ACTION
2026-03-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

TAFINLAR · ReferencePrescription
DABRAFENIB MESYLATE EQ 75MG BASE · CAPSULE · ORAL
TAFINLAR · ReferencePrescription
DABRAFENIB MESYLATE EQ 50MG BASE · CAPSULE · ORAL

Approval history

2026-03-26Labeling · Supplement 40 · standard — Label ↗AP
2025-04-07Labeling · Supplement 38 · standard — Label ↗AP
2025-03-19Labeling · Supplement 37 · standard — Label ↗AP
2025-03-07Efficacy · Supplement 33 · standard — Letter ↗AP
2025-01-30Labeling · Supplement 36 · standard — Label ↗AP
2024-07-11Labeling · Supplement 31 · standard — Letter ↗AP
2024-03-29Labeling · Supplement 30 · standard — Label ↗AP
2024-02-27Labeling · Supplement 29 · standard — Label ↗AP
2023-08-31Efficacy · Supplement 27 · priority — Letter ↗AP
2023-05-26Labeling · Supplement 26 · standard — Label ↗AP
2023-03-16Efficacy · Supplement 25 · priority — Label ↗AP
2022-06-22Efficacy · Supplement 22 · priority — Label ↗AP
2022-05-27Efficacy · Supplement 23 · standard — Letter ↗AP
2022-02-04Manufacturing (CMC) · Supplement 21 — Label ↗AP
2022-01-28Efficacy · Supplement 19 · standard — Letter ↗AP
2021-12-03Labeling · Supplement 20 · standard — Label ↗AP
2021-05-07Labeling · Supplement 17 · standard — Letter ↗AP
2020-04-09Labeling · Supplement 15 · standard — Letter ↗AP
2019-10-06Efficacy · Supplement 12 · standard — Label ↗AP
2019-07-16Labeling · Supplement 13 · standard — Label ↗AP
2018-05-04Efficacy · Supplement 10 · priority — Label ↗AP
2018-04-30Efficacy · Supplement 8 · priority — Label ↗AP
2018-04-20Labeling · Supplement 9 · standard — Label ↗AP
2017-06-22Efficacy · Supplement 6 · priority — Label ↗AP
2017-06-16Labeling · Supplement 7 · standard — Label ↗AP
2016-06-16Labeling · Supplement 5 · standard — Label ↗AP
2015-11-20Efficacy · Supplement 4 · unknown — Letter ↗AP
2014-08-25Manufacturing (CMC) · Supplement 3 · standardAP
2014-01-09Efficacy · Supplement 2 · priority — Review ↗AP
2013-12-26Labeling · Supplement 1 · standard — Label ↗AP
2013-05-29Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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