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FDA BLA · BLA022458

ELELYSO

taliglucerase alfa

Sponsor: PFIZER

APPLICATION
BLA022458
TYPE
BLA
ORIGINAL APPROVAL
2012-05-01
LATEST ACTION
2025-12-22
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

ELELYSOPrescription
TALIGLUCERASE ALFA 200 UNITS/VIAL · POWDER · INTRAVENOUS

Approval history

2025-12-22Labeling · Supplement 34 · standard — Letter ↗AP
2025-01-17Labeling · Supplement 33 · standard — Label ↗AP
2024-07-10Labeling · Supplement 31 · standard — Letter ↗AP
2023-05-09Labeling · Supplement 30 · standard — Letter ↗AP
2022-08-30Labeling · Supplement 29 · standard — Letter ↗AP
2020-11-03Labeling · Supplement 24 · standard — Label ↗AP
2019-10-21Labeling · Supplement 23 · standard — Letter ↗AP
2016-12-20Efficacy · Supplement 13 · standard — Letter ↗AP
2016-06-15Labeling · Supplement 12 · standard — Label ↗AP
2016-02-25Manufacturing (CMC) · Supplement 5 · standardAP
2015-12-23Manufacturing (CMC) · Supplement 8 · standardAP
2015-11-20Efficacy · Supplement 7 · standard — Label ↗AP
2014-08-27Labeling · Supplement 6 · standard — Label ↗AP
2014-08-27Efficacy · Supplement 3 · standard — Letter ↗AP
2014-06-24Manufacturing (CMC) · Supplement 4 · standardAP
2014-05-14Labeling · Supplement 2 · standard — Letter ↗AP
2014-01-13Manufacturing (CMC) · Supplement 1 · standardAP
2012-05-01Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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