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Drugs@FDA: FDA-Approved Drugs

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

Products on BLA 125559

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125559

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
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

Labels for BLA 125559

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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-30	Labeling-Patient 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-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125559s024lbl.pdf
03/10/2020	SUPPL-24	Labeling-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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