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FDA NDA · NDA208716

VERZENIO

abemaciclib

Sponsor: ELI LILLY AND CO

APPLICATION
NDA208716
TYPE
NDA
ORIGINAL APPROVAL
2017-09-28
LATEST ACTION
2026-07-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

VERZENIO · ReferencePrescription
ABEMACICLIB 200MG · TABLET · ORAL
VERZENIO · ReferencePrescription
ABEMACICLIB 100MG · TABLET · ORAL
VERZENIO · ReferencePrescription
ABEMACICLIB 150MG · TABLET · ORAL
VERZENIO · ReferencePrescription
ABEMACICLIB 50MG · TABLET · ORAL

Approval history

2026-07-13Efficacy · Supplement 21 · standard — Label ↗AP
2025-02-27Labeling · Supplement 19 · standard — Letter ↗AP
2024-11-13Efficacy · Supplement 17 · standard — Label ↗AP
2023-03-03Efficacy · Supplement 11 · standard — Label ↗AP
2023-03-03Efficacy · Supplement 10 · standard — Label ↗AP
2021-10-12Efficacy · Supplement 8 · standard — Label ↗AP
2021-10-12Efficacy · Supplement 6 · standard — Label ↗AP
2021-10-12Efficacy · Supplement 7 · standard — Label ↗AP
2020-03-30Efficacy · Supplement 4 · standard — Label ↗AP
2019-09-09Labeling · Supplement 3 · 901 required — Letter ↗AP
2018-08-17Labeling · Supplement 1 · standard — Letter ↗AP
2017-09-28Type 1 - New Molecular Entity · Original · priority — 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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