Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761108
Company: ALEXION PHARM
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 |