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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125513
Company: ALEXION PHARM

Summary Review

Products on BLA 125513

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
STRENSIQ	ASFOTASE ALFA	18MG/0.45ML	SOLUTION;INJECTION	Prescription	None	No	No
STRENSIQ	ASFOTASE ALFA	28MG/0.7ML	SOLUTION;INJECTION	Prescription	None	No	No
STRENSIQ	ASFOTASE ALFA	40MG/ML	SOLUTION;INJECTION	Prescription	None	No	No
STRENSIQ	ASFOTASE ALFA	80MG/0.8ML	SOLUTION;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125513

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/23/2015	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125513s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125513Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125513Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125513Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/10/2024	SUPPL-33	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125513s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125513Orig1s033ltr.pdf
06/12/2020	SUPPL-18	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125513s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125513Orig1s018ltr.pdf
01/26/2018	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125513s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125513Orig1s003ltr.pdf
10/18/2016	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125513s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125513Orig1s002ltr.pdf

Labels for BLA 125513

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/10/2024	SUPPL-33	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125513s033lbl.pdf
07/10/2024	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125513s033lbl.pdf
06/12/2020	SUPPL-18	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125513s018lbl.pdf
01/26/2018	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125513s003lbl.pdf
10/18/2016	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125513s002lbl.pdf
10/23/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125513s000lbl.pdf

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