General MedicationsSUBCUTANEOUSStandard
PYZCHIVA
USTEKINUMAB-TTWE
Standard Dose
130MG/26ML(5MG/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 761425 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient USTEKINUMAB-TTWE Form and strength INJECTABLE;SUBCUTANEOUS - 130MG/26ML(5MG/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 761425 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient USTEKINUMAB-TTWE Form and strength INJECTABLE;SUBCUTANEOUS - 130MG/26ML(5MG/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.