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General MedicationsINJECTIONStandard

BENLYSTA

BELIMUMAB

Standard Dose
120MG
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 125370 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient BELIMUMAB Form and strength INJECTABLE; INJECTION - 120MG Sponsor HUMAN GENOME SCIENCES INC.

Structured Monograph

Clinical summary

Approval overview BENLYSTA is listed in Drugs@FDA under application 125370 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient BELIMUMAB Form and strength INJECTABLE; INJECTION - 120MG Sponsor HUMAN GENOME SCIENCES INC. 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.