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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 022575
Company: SHIRE HUMAN GENETIC

This Former NDA Was Deemed To Be a BLA on March 23, 2020.

Products on BLA 022575

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VPRIV	VELAGLUCERASE ALFA	400 UNITS/VIAL	INJECTABLE;INTRAVENOUS	Prescription	None	No	No
VPRIV	VELAGLUCERASE ALFA	200 UNITS/VIAL	POWDER;INTRAVENOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 022575

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/26/2010	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022575lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022575s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022575s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/10/2020	SUPPL-26	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022575s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022575Orig1s026ltr.pdf
11/06/2019	SUPPL-23	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022575s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022575Orig1s023ltr.pdf
07/30/2019	SUPPL-22	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022575s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022575Orig1s022ltr.pdf
01/11/2016	SUPPL-18	Supplement		Label is not available on this site.
05/05/2015	SUPPL-17	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022575s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022575Orig1s017ltr.pdf
02/03/2015	SUPPL-16	Supplement		Label is not available on this site.
12/02/2014	SUPPL-15	Supplement		Label is not available on this site.
06/18/2014	SUPPL-14	Supplement		Label is not available on this site.
10/02/2013	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022575s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022575Orig1s013ltr.pdf
11/21/2013	SUPPL-12	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022575s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022575Orig1s012ltr.pdf
06/03/2013	SUPPL-11	Supplement		Label is not available on this site.
07/11/2014	SUPPL-10	Supplement		Label is not available on this site.
03/26/2013	SUPPL-9	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022575s007s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022575Orig1s007,s009ltr.pdf
02/11/2014	SUPPL-8	Supplement		Label is not available on this site.
03/26/2013	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022575s007s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022575Orig1s007,s009ltr.pdf

Labels for BLA 022575

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/10/2020	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022575s026lbl.pdf
11/06/2019	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022575s023lbl.pdf
07/30/2019	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022575s022lbl.pdf
05/05/2015	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022575s017lbl.pdf
11/21/2013	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022575s012lbl.pdf
10/02/2013	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022575s013lbl.pdf
03/26/2013	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022575s007s009lbl.pdf
03/26/2013	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022575s007s009lbl.pdf
02/26/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022575lbl.pdf

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