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FDA NDA · NDA214665

LUMAKRAS

sotorasib

Sponsor: AMGEN INC

APPLICATION
NDA214665
TYPE
NDA
ORIGINAL APPROVAL
2021-05-28
LATEST ACTION
2025-01-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LUMAKRAS · ReferencePrescription
SOTORASIB 320MG · TABLET · ORAL
LUMAKRAS · ReferencePrescription
SOTORASIB 240MG · TABLET · ORAL
LUMAKRAS · ReferencePrescription
SOTORASIB 120MG · TABLET · ORAL

Approval history

2025-01-16Efficacy · Supplement 9 · priority — Label ↗AP
2024-09-30Labeling · Supplement 12 · standard — Letter ↗AP
2023-04-24Labeling · Supplement 4 · standard — Label ↗AP
2023-03-17Labeling · Supplement 7 · standard — Letter ↗AP
2023-01-20Labeling · Supplement 3 · standard — Label ↗AP
2022-11-21Labeling · Supplement 2 · standard — Letter ↗AP
2021-05-28Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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