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FDA NDA · NDA210861

VITRAKVI

larotrectinib

Sponsor: BAYER HLTHCARE

APPLICATION
NDA210861
TYPE
NDA
ORIGINAL APPROVAL
2018-11-26
LATEST ACTION
2025-04-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

VITRAKVI · ReferencePrescription
LAROTRECTINIB SULFATE EQ 100MG BASE · CAPSULE · ORAL
VITRAKVI · ReferencePrescription
LAROTRECTINIB SULFATE EQ 25MG BASE · CAPSULE · ORAL

Approval history

2025-04-09Efficacy · Supplement 12 · standard — Letter ↗AP
2023-11-03Labeling · Supplement 10 · standard — Letter ↗AP
2022-11-23Labeling · Supplement 8 · standard — Letter ↗AP
2021-03-25Labeling · Supplement 6 · standard — Label ↗AP
2021-03-25Efficacy · Supplement 4 · standard — Letter ↗AP
2018-11-26Type 1 - New Molecular Entity · Original · priority — 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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