Fabrazyme

Treats confirmed Fabry disease. BLA 103979, held by Genzyme. Agalsidase Beta.

As of Nov 13, 2026, BLA 103979 (Fabrazyme), held by Genzyme, was first approved by FDA on Apr 24, 2003, with 10 approved supplements and 0 published complete response letters.

First approved: Apr 24, 2003
Review: Priority
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

FABRAZYME is indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Mar 11, 2021	Supplement 5309Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Sep 29, 2006	Supplement 5058Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 29, 2006	Supplement 5065Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 29, 2006	Supplement 5066Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 24, 2003	Original applicationNew molecular entity · Priority review	Approved	Label Review

Products

2 strengths and forms

Product	Active ingredient	Marketing
Fabrazyme5MG/VIAL · vial; intravenous	Agalsidase Beta	Rx
Fabrazyme35MG/VIAL · vial; intravenous	Agalsidase Beta	Rx

All 11 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 10, 2024	Supplement 5313Labeling · Standard review	Approved	Label Letter
Feb 6, 2024	Supplement 5312Labeling · Standard review	Approved	Letter Label
Mar 11, 2021	Supplement 5309Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Nov 1, 2019	Supplement 5306Labeling · Standard review	Approved	Letter
Dec 18, 2018	Supplement 5303Labeling · Standard review	Approved	Letter Label
May 14, 2010	Supplement 5135Labeling · Standard review	Approved	Label
Dec 17, 2008	Supplement 5107Labeling · Standard review	Approved	Label Letter
Sep 29, 2006	Supplement 5058Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 29, 2006	Supplement 5065Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 29, 2006	Supplement 5066Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 24, 2003	Original applicationNew molecular entity · Priority review	Approved	Label Review

Identifiers

Application: BLA 103979
Drugs@FDA: Overview at FDA
Company: Genzyme

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