Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125561
Company: ALEXION PHARM

Products on BLA 125561

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KANUMA	SEBELIPASE ALFA	20MG/10ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125561

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/08/2015	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125561s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125561Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125561Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/10/2024	SUPPL-20	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125561s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125561Orig1s020ltr.pdf
11/19/2021	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125561s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125561Orig1s013ltr.pdf

Labels for BLA 125561

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/10/2024	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125561s020lbl.pdf
11/19/2021	SUPPL-13	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125561s013lbl.pdf
12/08/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125561s000lbl.pdf