← FDA DRUG APPROVALS

FDA BLA · BLA022575

VPRIV

velaglucerase alfa

Sponsor: SHIRE HUMAN GENETIC

APPLICATION
BLA022575
TYPE
BLA
ORIGINAL APPROVAL
2010-02-26
LATEST ACTION
2024-07-10
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE, POWDER
MARKETING STATUS
Prescription, Discontinued

Products

VPRIVPrescription
VELAGLUCERASE ALFA 400 UNITS/VIAL · INJECTABLE · INTRAVENOUS
VPRIVDiscontinued
VELAGLUCERASE ALFA 200 UNITS/VIAL · POWDER · INTRAVENOUS

Approval history

2024-07-10Labeling · Supplement 30 · standard — Letter ↗AP
2020-12-10Labeling · Supplement 26 · standard — Label ↗AP
2019-11-06Labeling · Supplement 23 · standard — Letter ↗AP
2019-07-30Labeling · Supplement 22 · standard — Letter ↗AP
2016-01-11Manufacturing (CMC) · Supplement 18 · priorityAP
2015-05-05Labeling · Supplement 17 · standard — Label ↗AP
2015-02-03Manufacturing (CMC) · Supplement 16 · priorityAP
2014-12-02Manufacturing (CMC) · Supplement 15 · priorityAP
2014-07-11Manufacturing (CMC) · Supplement 10 · priorityAP
2014-06-18Manufacturing (CMC) · Supplement 14 · priorityAP
2014-02-11Manufacturing (CMC) · Supplement 8 · priorityAP
2013-11-21Efficacy · Supplement 12 · standard — Letter ↗AP
2013-10-02Labeling · Supplement 13 · standard — Letter ↗AP
2013-06-03Manufacturing (CMC) · Supplement 11 · priorityAP
2013-03-26Labeling · Supplement 9 · standard — Label ↗AP
2013-03-26Labeling · Supplement 7 · standard — Letter ↗AP
2010-02-26Type 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →