Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022575
Company: SHIRE HUMAN GENETIC
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
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 Type 1 - New Molecular Entity PRIORITY; 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
01/11/2016 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/05/2015 SUPPL-17 Labeling-Package Insert 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 Manufacturing (CMC)

Label is not available on this site.

12/02/2014 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/18/2014 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/02/2013 SUPPL-13 Labeling-Package Insert 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 Efficacy-Labeling Change With Clinical Data 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 Manufacturing (CMC)

Label is not available on this site.

07/11/2014 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/26/2013 SUPPL-9 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022575s007s009lbl.pdf
02/11/2014 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/26/2013 SUPPL-7 Labeling-Package Insert 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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