← FDA DRUG APPROVALS

FDA BLA · BLA103979

FABRAZYME

agalsidase beta

Sponsor: GENZYME

APPLICATION
BLA103979
TYPE
BLA
ORIGINAL APPROVAL
2003-04-24
LATEST ACTION
2024-07-10
ROUTE
INTRAVENOUS
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

FABRAZYMEPrescription
AGALSIDASE BETA 35MG/VIAL · VIAL · INTRAVENOUS
FABRAZYMEPrescription
AGALSIDASE BETA 5MG/VIAL · VIAL · INTRAVENOUS

Approval history

2024-07-10Labeling · Supplement 5313 · standard — Letter ↗AP
2024-02-06Labeling · Supplement 5312 · standard — Letter ↗AP
2021-03-11Efficacy · Supplement 5309 · standard — Letter ↗AP
2019-11-01Labeling · Supplement 5306 · standard — Letter ↗AP
2018-12-18Labeling · Supplement 5303 · standard — Label ↗AP
2010-05-14Labeling · Supplement 5135 · standard — Label ↗AP
2008-12-17Labeling · Supplement 5107 · standard — Label ↗AP
2006-09-29Efficacy · Supplement 5066 · standard — Letter ↗AP
2006-09-29Efficacy · Supplement 5058 · standard — Letter ↗AP
2006-09-29Efficacy · Supplement 5065 · standard — Label ↗AP
2003-04-24Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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