Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125166
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
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)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125166s422lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125166Orig1s422ltr.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
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

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