Vpriv

BLA 22575, held by Shire Human Genetic. Velaglucerase Alfa.

As of Nov 13, 2026, BLA 22575 (Vpriv), held by Shire Human Genetic, was first approved by FDA on Feb 26, 2010, with 16 approved supplements and 0 published complete response letters.

First approved: Feb 26, 2010
Review: Priority
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Nov 21, 2013	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 26, 2010	Original applicationNew molecular entity · Priority review	Approved	Letter Label Review

Products

2 strengths and forms

Product	Active ingredient	Marketing
Vpriv400 UNITS/VIAL · injectable;intravenous	Velaglucerase Alfa	Rx
Vpriv200 UNITS/VIAL · powder;intravenous	Velaglucerase Alfa	Discontinued

All 17 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 10, 2024	Supplement 30Labeling · Standard review	Approved	Label Letter
Dec 10, 2020	Supplement 26Labeling · Standard review	Approved	Letter Label
Nov 6, 2019	Supplement 23Labeling · Standard review	Approved	Letter Label
Jul 30, 2019	Supplement 22Labeling · Standard review	Approved	Letter Label
Jan 11, 2016	Supplement 18Manufacturing · Priority review	Approved	None posted
May 5, 2015	Supplement 17Labeling · Standard review	Approved	Letter Label
Feb 3, 2015	Supplement 16Manufacturing · Priority review	Approved	None posted
Dec 2, 2014	Supplement 15Manufacturing · Priority review	Approved	None posted
Jul 11, 2014	Supplement 10Manufacturing · Priority review	Approved	None posted
Jun 18, 2014	Supplement 14Manufacturing · Priority review	Approved	None posted
Feb 11, 2014	Supplement 8Manufacturing · Priority review	Approved	None posted
Nov 21, 2013	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 2, 2013	Supplement 13Labeling · Standard review	Approved	Letter Label
Jun 3, 2013	Supplement 11Manufacturing · Priority review	Approved	None posted
Mar 26, 2013	Supplement 9Labeling · Standard review	Approved	Letter Label
Mar 26, 2013	Supplement 7Labeling · Standard review	Approved	Letter Label
Feb 26, 2010	Original applicationNew molecular entity · Priority review	Approved	Letter Label Review

Identifiers

Application: BLA 22575
Drugs@FDA: Overview at FDA
Company: Shire Human Genetic

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters