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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125522
Company: AMGEN INC

Summary Review

Products on BLA 125522

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
REPATHA	EVOLOCUMAB	140MG/ML	INJECTABLE;INJECTION	Prescription	None	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125522

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/26/2021	ORIG-2	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125522orig2s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125522Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/125522Orig2s000TOC.cfm
08/27/2015	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125522s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125522Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125522Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125522Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/16/2022	SUPPL-33	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125522s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125522Orig1s033ltr.pdf
09/24/2021	SUPPL-31	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125522Orig1s031ltr.pdf
09/24/2021	SUPPL-29	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125522s029s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125522Orig1s029ltr.pdf
05/06/2020	SUPPL-24	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125522Orig1s024ltr.pdf
02/15/2019	SUPPL-22	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125522s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125522Orig1s022ltr.pdf
04/11/2019	SUPPL-20	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125522Orig1s020ltr.pdf
02/15/2019	SUPPL-19	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125522s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125522Orig1s019ltr_Replacement.pdf
10/18/2018	SUPPL-17	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125522s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125522Orig1s017ltr.pdf
12/01/2017	SUPPL-14	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125522s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125522s014ltr.pdf
12/01/2017	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125522s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125522s013ltr.pdf
01/03/2017	SUPPL-11	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125522s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125522Orig1s011ltr.pdf
01/25/2017	SUPPL-9	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125522s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125522Orig1s009ltr.pdf
11/30/2016	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125522s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125522Orig1s008ltr.pdf
07/08/2016	SUPPL-4	Supplement	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125522Orig1s001,s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125522Orig1s004.pdf
07/08/2016	SUPPL-1	Supplement	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125522Orig1s001,s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125522Orig1s001.pdf

Labels for BLA 125522

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/16/2022	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125522s033lbl.pdf
09/24/2021	SUPPL-29	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125522s029s031lbl.pdf
02/26/2021	ORIG-2	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125522orig2s000lbl.pdf
02/15/2019	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125522s022lbl.pdf
02/15/2019	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125522s019lbl.pdf
02/15/2019	SUPPL-19	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125522s019lbl.pdf
10/18/2018	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125522s017lbl.pdf
12/01/2017	SUPPL-14	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125522s014lbl.pdf
12/01/2017	SUPPL-13	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125522s013lbl.pdf
01/25/2017	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125522s009lbl.pdf
01/03/2017	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125522s011lbl.pdf
11/30/2016	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125522s008lbl.pdf
08/27/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125522s000lbl.pdf

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