Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 103979
Company: GENZYME
Company: GENZYME
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FABRAZYME | AGALSIDASE BETA | 5MG/VIAL | VIAL; INTRAVENOUS | Prescription | None | No | No |
FABRAZYME | AGALSIDASE BETA | 35MG/VIAL | VIAL; INTRAVENOUS | 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 |
---|---|---|---|---|---|---|---|
04/24/2003 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/agalgen042403LB.pdf https://web.archive.org/web/20170202073410/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm128159.htm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/103979_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/06/2024 | SUPPL-5312 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103979s5312lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/103979Orig1s5312ltr.pdf | |
03/11/2021 | SUPPL-5309 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103979s5309lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103979Orig1s5309ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/103979Orig1s5309.pdf | |
11/01/2019 | SUPPL-5306 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103979Orig1s5306ltr.pdf |
12/18/2018 | SUPPL-5303 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103979s5303lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103979Orig1s5303ltr.pdf | |
05/14/2010 | SUPPL-5135 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103979s5135lbl.pdf | |
12/17/2008 | SUPPL-5107 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103979s5107lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103979s5107ltr.pdf | |
09/29/2006 | SUPPL-5066 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103979_S5058,S5065,S5066LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103979_S5058,S5065,S5066LTR.pdf | |
09/29/2006 | SUPPL-5065 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103979_S5058,S5065,S5066LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103979_S5058,S5065,S5066LTR.pdf | |
09/29/2006 | SUPPL-5058 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103979_S5058,S5065,S5066LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103979_S5058,S5065,S5066LTR.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/06/2024 | SUPPL-5312 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103979s5312lbl.pdf | |
03/11/2021 | SUPPL-5309 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103979s5309lbl.pdf | |
12/18/2018 | SUPPL-5303 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103979s5303lbl.pdf | |
12/18/2018 | SUPPL-5303 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103979s5303lbl.pdf | |
05/14/2010 | SUPPL-5135 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103979s5135lbl.pdf | |
12/17/2008 | SUPPL-5107 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103979s5107lbl.pdf | |
09/29/2006 | SUPPL-5066 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103979_S5058,S5065,S5066LBL.pdf | |
09/29/2006 | SUPPL-5065 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103979_S5058,S5065,S5066LBL.pdf | |
09/29/2006 | SUPPL-5058 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103979_S5058,S5065,S5066LBL.pdf | |
04/24/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/agalgen042403LB.pdf |