← FDA DRUG APPROVALS

FDA NDA · NDA210496

BRAFTOVI

encorafenib

Sponsor: ARRAY BIOPHARMA INC

APPLICATION
NDA210496
TYPE
NDA
ORIGINAL APPROVAL
2018-06-27
LATEST ACTION
2026-02-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued, Prescription

Products

BRAFTOVI · ReferenceDiscontinued
ENCORAFENIB 50MG · CAPSULE · ORAL
BRAFTOVI · ReferencePrescription
ENCORAFENIB 75MG · CAPSULE · ORAL

Approval history

2026-02-24Efficacy · Supplement 19 · standard — Label ↗AP
2026-02-24Efficacy · Supplement 21 · standard — Label ↗AP
2025-03-12Efficacy · Supplement 18 · standard — Letter ↗AP
2024-12-20Efficacy · Supplement 17 · priority — Label ↗AP
2024-09-12Efficacy · Supplement 16 · standard — Label ↗AP
2023-10-13Labeling · Supplement 15 · standard — Letter ↗AP
2023-10-11Efficacy · Supplement 14 · standard — Label ↗AP
2022-02-11Labeling · Supplement 13 · standard — Label ↗AP
2020-04-08Efficacy · Supplement 6 · priority — Label ↗AP
2019-05-24Efficacy · Supplement 3 · standard — Label ↗AP
2019-01-23Efficacy · Supplement 1 · standard — Label ↗AP
2018-06-27Type 1 - New Molecular Entity · Original · standard — Label ↗AP
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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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