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General MedicationsINJECTIONStandard

PYZCHIVA

USTEKINUMAB-TTWE

Standard Dose
90MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview PYZCHIVA is listed in Drugs@FDA under application 761373 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient USTEKINUMAB-TTWE Form and strength INJECTABLE;INJECTION - 90MG/ML Sponsor SAMSUNG BIOEPIS CO LTD Submission history Latest submission status date: 2025-11-18 00:00:00.

Structured Monograph

Clinical summary

Approval overview PYZCHIVA is listed in Drugs@FDA under application 761373 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient USTEKINUMAB-TTWE Form and strength INJECTABLE;INJECTION - 90MG/ML Sponsor SAMSUNG BIOEPIS CO LTD Submission history Latest submission status date: 2025-11-18 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.