General MedicationsINJECTIONStandard
BENLYSTA
BELIMUMAB
Standard Dose
200MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview BENLYSTA is listed in Drugs@FDA under application 761043 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient BELIMUMAB Form and strength INJECTABLE;INJECTION - 200MG/ML Sponsor GLAXOSMITHKLINE LLC Submission history Latest submission status date: 2025-06-20 00:00:00.
Structured Monograph
Clinical summary
Approval overview BENLYSTA is listed in Drugs@FDA under application 761043 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient BELIMUMAB Form and strength INJECTABLE;INJECTION - 200MG/ML Sponsor GLAXOSMITHKLINE LLC Submission history Latest submission status date: 2025-06-20 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.