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Voyxact

sibeprenlimab-szsi

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Voyxact

Proper name

sibeprenlimab-szsi

Licence type

351(a)

BLA number

761434

Applicant

Otsuka Pharmaceutical Company, Ltd.

Center

CDER

Presentations

1

First licensure

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Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
400MG/2ML (200MG/ML)	Injection	Subcutaneous	Pre-Filled Syringe	Rx	November 25, 2025

Sources for this page

Purple Book	FDA	Licence type, presentations, reference product, exclusivity