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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761108
Company: ALEXION PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ULTOMIRIS RAVULIZUMAB-CWVZ 300MG/30ML(10MG/ML) 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
12/21/2018 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761108s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761108Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761108Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/19/2024 SUPPL-37 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761108s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761108Orig1s037ltr.pdf
06/28/2024 SUPPL-36 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761108s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761108Orig1s036ltr.pdf
02/08/2024 SUPPL-35 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761108s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761108Orig1s035ltr.pdf
03/22/2024 SUPPL-31 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761108s026s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/2024/761108Orig1s026; s031ltr.pdf
03/22/2024 SUPPL-26 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761108s026s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761108Orig1s026; s031ltr.pdf
11/22/2021 SUPPL-24 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761108Orig1s024Corrected_ltr.pdf
04/27/2022 SUPPL-23 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761108s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761108Orig1s023ltr.pdf
07/22/2022 SUPPL-21 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761108s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761108Orig1s021correctedltr.pdf
01/07/2022 SUPPL-20 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761108s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761108Orig1s020ltr.pdf
04/22/2021 SUPPL-15 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761108Orig1s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761108Orig1s015ltr.pdf
06/07/2021 SUPPL-12 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761108s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761108Orig1s012ltr.pdf
04/30/2020 SUPPL-7 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761108Orig1s007ltr.pdf
10/09/2020 SUPPL-5 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761108s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761108Orig1s005ltr.pdf
10/18/2019 SUPPL-1 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761108s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761108Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/19/2024 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761108s037lbl.pdf
06/28/2024 SUPPL-36 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761108s036lbl.pdf
06/28/2024 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761108s036lbl.pdf
03/22/2024 SUPPL-31 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761108s026s031lbl.pdf
03/22/2024 SUPPL-26 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761108s026s031lbl.pdf
02/08/2024 SUPPL-35 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761108s035lbl.pdf
02/08/2024 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761108s035lbl.pdf
07/22/2022 SUPPL-21 Efficacy-New Route Of Administration Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761108s021lbl.pdf
04/27/2022 SUPPL-23 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761108s023lbl.pdf
01/07/2022 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761108s020lbl.pdf
06/07/2021 SUPPL-12 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761108s012lbl.pdf
04/22/2021 SUPPL-15 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761108Orig1s015lbl.pdf
10/09/2020 SUPPL-5 Efficacy-Manufacturing Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761108s005lbl.pdf
10/18/2019 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761108s001lbl.pdf
12/21/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761108s000lbl.pdf
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