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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761108
Company: ALEXION PHARM

Medication Guide

REMS

Products on BLA 761108

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761108

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
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

Labels for BLA 761108

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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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