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General MedicationsINJECTIONStandard

VOYXACT

SIBEPRENLIMAB-SZSI

Standard Dose
400MG/2ML(200MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview VOYXACT is listed in Drugs@FDA under application 761434 (BLA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient SIBEPRENLIMAB-SZSI Form and strength INJECTABLE;INJECTION - 400MG/2ML(200MG/ML) Sponsor OTSUKA PHARM CO LTD Submission history Latest submission status date: 2025-11-25 00:00:00.

Structured Monograph

Clinical summary

Approval overview VOYXACT is listed in Drugs@FDA under application 761434 (BLA). Review priority: PRIORITY Marketing status: Prescription Active ingredient SIBEPRENLIMAB-SZSI Form and strength INJECTABLE;INJECTION - 400MG/2ML(200MG/ML) Sponsor OTSUKA PHARM CO LTD Submission history Latest submission status date: 2025-11-25 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: PRIORITY

Interaction Notes

  • No interaction notes stored yet.