Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125166
Company: ALEXION PHARM
Company: ALEXION PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SOLIRIS | ECULIZUMAB | 300MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/16/2007 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125166lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125166s0000_LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/125166s0000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/08/2024 | SUPPL-446 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125166s446lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125166Orig1s446ltr.pdf | |
| 03/22/2024 | SUPPL-443 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125166s443lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125166Orig1s443ltr.pdf | |
| 11/20/2020 | SUPPL-434 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125166s434lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125166Orig1s434ltr.pdf | |
| 04/07/2020 | SUPPL-432 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125166Orig1s432ltr.pdf |
| 06/27/2019 | SUPPL-431 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125166s431lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125166Orig1s431ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/125166Orig1s431.pdf | |
| 07/25/2018 | SUPPL-428 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125166s047s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125166Orig1s427s428Ltr.pdf | |
| 07/25/2018 | SUPPL-427 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125166s047s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125166Orig1s427s428Ltr.pdf | |
| 02/28/2018 | SUPPL-426 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125166s426lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125166Orig1s426ltr.pdf | |
| 10/23/2017 | SUPPL-422 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125166s422lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125166Orig1s422ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/125166Orig1s422.pdf | |
| 01/13/2017 | SUPPL-417 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125166s417lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125166Orig1s417ltr.pdf | |
| 04/13/2016 | SUPPL-414 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125166Orig1s414ltr.pdf |
| 12/03/2015 | SUPPL-413 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125166s413lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125166Orig1s412,s413ltr.pdf | |
| 12/03/2015 | SUPPL-412 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125166Orig1s412,s413ltr.pdf |
| 10/10/2014 | SUPPL-409 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125166Orig1s409ltr.pdf |
| 04/30/2014 | SUPPL-380 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125166s368s380lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125166Orig1s368,125166Orig1s380ltr.pdf | |
| 04/30/2014 | SUPPL-368 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125166s368s380lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125166Orig1s368,125166Orig1s380ltr.pdf | |
| 12/21/2012 | SUPPL-273 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125166Orig1s273ltr.pdf |
| 09/23/2011 | SUPPL-172 | Supplement |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125166s172lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2011/125166Orig1s172-2.pdf | |
| 06/04/2010 | SUPPL-44 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125166s044ltr.pdf |
| 06/30/2009 | SUPPL-33 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125166s0033ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/22/2024 | SUPPL-443 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125166s443lbl.pdf | |
| 02/08/2024 | SUPPL-446 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125166s446lbl.pdf | |
| 02/08/2024 | SUPPL-446 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125166s446lbl.pdf | |
| 11/20/2020 | SUPPL-434 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125166s434lbl.pdf | |
| 11/20/2020 | SUPPL-434 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125166s434lbl.pdf | |
| 06/27/2019 | SUPPL-431 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125166s431lbl.pdf | |
| 07/25/2018 | SUPPL-428 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125166s047s048lbl.pdf | |
| 07/25/2018 | SUPPL-427 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125166s047s048lbl.pdf | |
| 07/25/2018 | SUPPL-427 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125166s047s048lbl.pdf | |
| 02/28/2018 | SUPPL-426 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125166s426lbl.pdf | |
| 10/23/2017 | SUPPL-422 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125166s422lbl.pdf | |
| 01/13/2017 | SUPPL-417 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125166s417lbl.pdf | |
| 01/13/2017 | SUPPL-417 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125166s417lbl.pdf | |
| 01/13/2017 | SUPPL-417 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125166s417lbl.pdf | |
| 12/03/2015 | SUPPL-413 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125166s413lbl.pdf | |
| 04/30/2014 | SUPPL-380 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125166s368s380lbl.pdf | |
| 04/30/2014 | SUPPL-368 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125166s368s380lbl.pdf | |
| 09/23/2011 | SUPPL-172 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125166s172lbl.pdf | |
| 03/16/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125166lbl.pdf |