← FDA Drug Approvals (Drugs@FDA)

VOYXACT

BLA · Biologics License Application · Sponsor: OTSUKA PHARM CO LTD · Approved 2025-11-25

Drug application

FDA Application #

BLA761434

Application type

Biologics License Application

Brand name

VOYXACT

Generic name

SIBEPRENLIMAB

Active ingredients

SIBEPRENLIMAB-SZSI

Dosage form

INJECTABLE

Route

INJECTION

Marketing status

Prescription

Sponsor

OTSUKA PHARM CO LTD

Manufacturer

Otsuka America Pharmaceutical, Inc.

First approval

2025-11-25

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown