FDA BLA · BLA125291

LUMIZYME

alglucosidase alfa

Sponsor: GENZYME

APPLICATION

BLA125291

TYPE

BLA

ORIGINAL APPROVAL

2010-05-24

LATEST ACTION

2024-12-30

ROUTE

INTRAVENOUS, IV (INFUSION)

DOSAGE FORM

POWDER

MARKETING STATUS

Prescription

Products

LUMIZYMEPrescription

ALGLUCOSIDASE ALFA 5MG/ML · POWDER · IV (INFUSION)

2024-12-30Labeling · Supplement 161 · standard — Label ↗AP

2024-03-22Labeling · Supplement 160 · standard — Label ↗AP

2023-05-24Labeling · Supplement 159 · standard — Letter ↗AP

2022-05-12Labeling · Supplement 157 · standard — Letter ↗AP

2022-05-12Labeling · Supplement 156 · standard — Letter ↗AP

2020-02-18Labeling · Supplement 151 · standard — Label ↗AP

2019-05-30Labeling · Supplement 148 · standard — Label ↗AP

2014-08-01Efficacy · Supplement 136 · priority — Label ↗AP

2014-05-22Labeling · Supplement 133 · standard — Letter ↗AP

2012-07-16Labeling · Supplement 79 · standard — Letter ↗AP

2012-07-09Labeling · Supplement 63 · standard — Label ↗AP

2011-09-12Labeling · Supplement 43 · standardAP

2010-05-24Type 1 - New Molecular Entity · Original · priority — Letter ↗AP

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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