Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 022575
Company: SHIRE HUMAN GENETIC
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 | 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 |
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 |