General MedicationsORALStandard
WAYRILZ
RILZABRUTINIB
Standard Dose
400MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview WAYRILZ is listed in Drugs@FDA under application 219685 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient RILZABRUTINIB Form and strength TABLET;ORAL - 400MG Sponsor GENZYME CORP Submission history Latest submission status date: 2025-08-29 00:00:00.
Structured Monograph
Clinical summary
Approval overview WAYRILZ is listed in Drugs@FDA under application 219685 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient RILZABRUTINIB Form and strength TABLET;ORAL - 400MG Sponsor GENZYME CORP Submission history Latest submission status date: 2025-08-29 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.