Xiaflex

Treats Dupuytren’s contracture with a palpable cord. BLA 125338, held by Auxilium Pharms. Collagenase Clostridium Histolyticum.

As of Nov 13, 2026, BLA 125338 (Xiaflex), held by Auxilium Pharms, was first approved by FDA on Feb 2, 2010, with 19 approved supplements and 0 published complete response letters.

First approved: Feb 2, 2010
Review: Priority
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

XIAFLEX is indicated for the treatment of adult patients with Dupuytren’s contracture with a palpable cord. XIAFLEX is indicated for 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. XIAFLEX is a combination of bacterial collagenases indicated for the treatment of: Adult patients with Dupuytren’s contracture with a palpable cord Adult men with Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
May 15, 2015	Supplement 85Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 15, 2015	Supplement 87Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 15, 2015	Supplement 88Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 20, 2014	Supplement 84Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 6, 2013	Supplement 61Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 2, 2010	Original applicationNew molecular entity · Priority review	Approved	Other Review Summary Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Xiaflex0.9MG · solution; injection	Collagenase Clostridium Histolyticum	Rx

All 20 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 11, 2024	Supplement 138REMS	Approved	Letter
Jul 12, 2023	Supplement 111Labeling · Standard review	Approved	Label Medication Guide Letter
Nov 2, 2022	Supplement 128REMS	Approved	Letter
Aug 1, 2022	Supplement 129Labeling · Standard review	Approved	Label Letter
Jun 9, 2022	Supplement 127REMS	Approved	Letter
Jan 11, 2022	Supplement 121REMS	Approved	Letter
Aug 19, 2021	Supplement 117Labeling · Standard review	Approved	Letter Label
Apr 13, 2021	Supplement 112Labeling · Standard review	Approved	Label Letter
Sep 26, 2018	Supplement 110REMS	Approved	Letter
Jun 6, 2018	Supplement 109Labeling · Standard review	Approved	Letter Label
Nov 28, 2016	Supplement 100REMS	Approved	Letter
Nov 28, 2016	Supplement 101REMS	Approved	Letter
Sep 19, 2016	Supplement 102Labeling · Standard review	Approved	Letter Label
May 15, 2015	Supplement 85Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 15, 2015	Supplement 87Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 15, 2015	Supplement 88Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 20, 2014	Supplement 84Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 6, 2013	Supplement 61Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 24, 2012	Supplement 40Labeling · Standard review	Approved	Label Letter
Feb 2, 2010	Original applicationNew molecular entity · Priority review	Approved	Other Review Summary Review Letter

Identifiers

Application: BLA 125338
Drugs@FDA: Overview at FDA
Company: Auxilium Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters