← FDA Drug Approvals (Drugs@FDA)
PYZCHIVA
BLA · Biologics License Application · Sponsor: SAMSUNG BIOEPIS CO LTD · Approved 2025-04-30
Drug application
- FDA Application #
BLA761425- Application type
- Biologics License Application
- Brand name
- PYZCHIVA
- Generic name
- USTEKINUMAB-TTWE
- Active ingredients
- USTEKINUMAB-TTWE
- Dosage form
- INJECTABLE
- Route
- SUBCUTANEOUS
- Marketing status
- Prescription
- Sponsor
- SAMSUNG BIOEPIS CO LTD
- Manufacturer
- Quallent Pharmaceuticals Health LLC
- First approval
- 2025-04-30
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown