Skip to content

On this page

Vyloy

zolbetuximab-clzb

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Vyloy

Proper name

zolbetuximab-clzb

Licence type

351(a)

BLA number

761365

Applicant

Astellas Pharma US, Inc.

Center

CDER

Presentations

2

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
100MG	For Injection	Intravenous	Single-Dose Vial	Rx	October 18, 2024
300MG	For Injection	Intravenous	Single-Dose Vial	Rx	March 24, 2025

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	October 18, 1931

Sources for this page

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