Is Pegloticase approved by the US FDA?

Drugs@FDA lists 1 application product line for Pegloticase, including KRYSTEXXA (Prescription).

Is Pegloticase authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Pegloticase.

Are there safety signals or safety updates for Pegloticase?

US FDA: 1 entry (latest 2022-07-07).

Active substance

Pegloticase

US FDA 1
EMA 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
KRYSTEXXA	8MG	injectable · injection	HORIZON PHARMA	Prescription	14 Sep 2010

EMA European Union — centrally authorised medicines

Krystexxa Crealta Pharmaceuticals Ireland Limited · Withdrawn · authorised 8 Jan 2013 · ATC M04AX02

Therapeutic indication (EMA)

Krystexxa is indicated for the treatment of severe debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated.

Safety signals and safety-related labeling changes

US FDA 7 Jul 2022 KRYSTEXXA — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for pegloticase →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.