← FDA DRUG APPROVALS

FDA BLA · BLA125117

NAGLAZYME

galsulfase

Sponsor: BIOMARIN

APPLICATION
BLA125117
TYPE
BLA
ORIGINAL APPROVAL
2005-05-31
LATEST ACTION
2024-09-12
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

NAGLAZYMEPrescription
GALSULFASE 5MG/5ML · INJECTABLE · INJECTION

Approval history

2024-09-12Labeling · Supplement 132 · standard — Label ↗AP
2024-07-10Labeling · Supplement 131 · standard — Letter ↗AP
2019-12-17Labeling · Supplement 129 · standard — Label ↗AP
2013-03-26Labeling · Supplement 111 · standard — Label ↗AP
2011-04-28Efficacy · Supplement 88 · standard — Label ↗AP
2011-04-28Efficacy · Supplement 86 · standard — Label ↗AP
2011-04-28Efficacy · Supplement 90 · standard — Label ↗AP
2005-05-31Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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