Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125117
Company: BIOMARIN
Company: BIOMARIN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NAGLAZYME | GALSULFASE | 5MG/5ML | INJECTABLE; INJECTION | Prescription | 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 |
---|---|---|---|---|---|---|---|
05/31/2005 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125117_0000_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125117_0000_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/125117s000_NaglazyneTOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/12/2024 | SUPPL-132 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125117s132lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125117Orig1s132ltr.pdf | |
07/10/2024 | SUPPL-131 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125117s131lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125117Orig1s131ltr.pdf | |
12/17/2019 | SUPPL-129 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125117s129lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125117Orig1s129ltr.pdf | |
03/26/2013 | SUPPL-111 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125117s111lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125117Orig1s111ltr.pdf | |
04/28/2011 | SUPPL-90 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125117s0086s0088s0090lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125117s086s088s090ltr.pdf | |
04/28/2011 | SUPPL-88 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125117s0086s0088s0090lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125117s086s088s090ltr.pdf | |
04/28/2011 | SUPPL-86 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125117s0086s0088s0090lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125117s086s088s090ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/12/2024 | SUPPL-132 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125117s132lbl.pdf | |
07/10/2024 | SUPPL-131 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125117s131lbl.pdf | |
12/17/2019 | SUPPL-129 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125117s129lbl.pdf | |
03/26/2013 | SUPPL-111 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125117s111lbl.pdf | |
04/28/2011 | SUPPL-90 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125117s0086s0088s0090lbl.pdf | |
04/28/2011 | SUPPL-88 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125117s0086s0088s0090lbl.pdf | |
04/28/2011 | SUPPL-86 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125117s0086s0088s0090lbl.pdf | |
05/31/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125117_0000_lbl.pdf |