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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125559
Company: REGENERON PHARMACEUTICALS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRALUENT ALIROCUMAB 75MG INJECTABLE;INJECTION Prescription None TBD No
PRALUENT ALIROCUMAB 150MG INJECTABLE;INJECTION Prescription None TBD 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
07/24/2015 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125559Orig1s000lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125559Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125559Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/08/2024 SUPPL-39 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125559s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125559Orig1s039ltr.pdf
04/01/2021 SUPPL-30 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125559s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125559Orig1s029,s030ltr.pdf
04/01/2021 SUPPL-29 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125559s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125559Orig1s029,s030ltr.pdf
03/10/2020 SUPPL-24 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125559s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125559Orig1s024ltr.pdf
04/26/2019 SUPPL-20 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125559s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125559Orig1s019, s020ltr.pdf
04/26/2019 SUPPL-19 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125559s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125559Orig1s019, s020ltr.pdf
11/06/2018 SUPPL-18 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125559s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125559Orig1s018ltr.pdf
07/20/2018 SUPPL-15 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125559s015lbl.pdf
08/22/2018 SUPPL-14 Supplement Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125559s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125559Orig1s014Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/125559Orig1s014TOC.cfm
09/20/2017 SUPPL-6 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125559s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125559Orig1s006ltr.pdf
07/27/2017 SUPPL-2 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125559s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125559Orig1s002ltr.pdf
04/24/2017 SUPPL-1 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125559s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125559Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/08/2024 SUPPL-39 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125559s039lbl.pdf
04/01/2021 SUPPL-30 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125559s029s030lbl.pdf
04/01/2021 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125559s029s030lbl.pdf
04/01/2021 SUPPL-29 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125559s029s030lbl.pdf
03/10/2020 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125559s024lbl.pdf
03/10/2020 SUPPL-24 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125559s024lbl.pdf
04/26/2019 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125559s019s020lbl.pdf
04/26/2019 SUPPL-19 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125559s019s020lbl.pdf
11/06/2018 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125559s018lbl.pdf
08/22/2018 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125559s014lbl.pdf
07/20/2018 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125559s015lbl.pdf
07/20/2018 SUPPL-15 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125559s015lbl.pdf
09/20/2017 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125559s006lbl.pdf
07/27/2017 SUPPL-2 Manufacturing (CMC) Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125559s002lbl.pdf
04/24/2017 SUPPL-1 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125559s001lbl.pdf
07/24/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125559Orig1s000lbledt.pdf
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