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Krystexxa

pegloticase

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Krystexxa

Proper name

pegloticase

Licence type

351(a)

BLA number

125293

Applicant

Horizon Therapeutics Ireland DAC

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
8MG/50ML (0.16MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	August 29, 2025
8MG/ML	Injection	Intravenous	Single-Dose Vial	Rx	September 14, 2010

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	September 14, 2017

Sources for this page

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