Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125141
Company: GENZYME
Company: GENZYME
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MYOZYME | ALGLUCOSIDASE ALFA | 20MG/KG | INJECTABLE; IV (INFUSION) | 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 |
---|---|---|---|---|---|---|---|
04/28/2006 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125141LBLini.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125141s0_LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/125141s000_MyozymeTOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/18/2020 | SUPPL-223 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125141s223lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125141Orig1s223,125291Orig1s151ltr.pdf | |
05/30/2019 | SUPPL-222 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125141s222lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125141Orig1s222, 125291Orig1s148ltr.pdf | |
05/20/2014 | SUPPL-219 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125141s219lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125141Orig1s219ltr.pdf | |
07/09/2012 | SUPPL-176 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125141s0176lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125141Orig1s0176ltr.pdf | |
06/11/2010 | SUPPL-116 | Supplement |
Label is not available on this site. |
||
12/08/2008 | SUPPL-74 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125141_74lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125141s074ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/18/2020 | SUPPL-223 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125141s223lbl.pdf | |
05/30/2019 | SUPPL-222 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125141s222lbl.pdf | |
05/20/2014 | SUPPL-219 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125141s219lbl.pdf | |
07/09/2012 | SUPPL-176 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125141s0176lbl.pdf | |
12/08/2008 | SUPPL-74 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125141_74lbl.pdf | |
04/28/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125141LBLini.pdf |