An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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
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
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

Top