Is Collagenase clostridium histolyticum approved by the US FDA?

Drugs@FDA lists 2 application product lines for Collagenase clostridium histolyticum, including XIAFLEX (Prescription); QWO (Prescription).

Is Collagenase clostridium histolyticum authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Collagenase clostridium histolyticum.

Are there safety signals or safety updates for Collagenase clostridium histolyticum?

US FDA: 1 entry (latest 2023-07-12).

Active substance

Collagenase clostridium histolyticum

US FDA 2
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
XIAFLEX	0.9MG	solution · injection	AUXILIUM PHARMS	Prescription	2 Feb 2010
QWO	0.92MG/VIAL; 1.84MG/VIAL	solution · subcutaneous	ENDO GLOBAL AESTHETICS LTD	Prescription	6 Jul 2020

EMA European Union — centrally authorised medicines

Xiapex Swedish Orphan Biovitrum AB · Withdrawn · authorised 28 Feb 2011 · ATC M09AB02

Therapeutic indication (EMA)

The treatment of Dupuytren’s contracture in adult patients with a palpable cord. The treatment of adult men with Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.

Safety signals and safety-related labeling changes

US FDA 12 Jul 2023 XIAFLEX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for collagenase clostridium histolyticum →

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.