General MedicationsORALStandard
LUMAKRAS
SOTORASIB
Standard Dose
240MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary
Approval overview LUMAKRAS is listed in Drugs@FDA under application 214665 (NDA).
Review priority: PRIORITY Marketing status: Prescription Active ingredient SOTORASIB Form and strength TABLET;ORAL - 240MG Sponsor AMGEN INC Submission history Latest submission status date: 2025-01-16 00:00:00.
Structured Monograph
Clinical summary
Approval overview LUMAKRAS is listed in Drugs@FDA under application 214665 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient SOTORASIB Form and strength TABLET;ORAL - 240MG Sponsor AMGEN INC Submission history Latest submission status date: 2025-01-16 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: PRIORITY
Interaction Notes
- No interaction notes stored yet.