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Drugs@FDA: FDA-Approved Drugs

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