General MedicationsORALStandard
LORBRENA
LORLATINIB
Standard Dose
25MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview LORBRENA is listed in Drugs@FDA under application 210868 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient LORLATINIB Form and strength TABLET;ORAL - 25MG Sponsor PFIZER Submission history Latest submission status date: 2026-01-29 00:00:00.
Structured Monograph
Clinical summary
Approval overview LORBRENA is listed in Drugs@FDA under application 210868 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient LORLATINIB Form and strength TABLET;ORAL - 25MG Sponsor PFIZER Submission history Latest submission status date: 2026-01-29 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.