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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761077
Company: AMGEN INC

Products on BLA 761077

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AIMOVIG	ERENUMAB-AOOE	70MG/ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761077

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/17/2018	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761077s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761077Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761077Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/22/2022	SUPPL-17	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761077Orig1s017Correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761077Orig1s017Correctedltr.pdf
08/15/2022	SUPPL-16	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761077Orig1s016ltr.pdf
10/03/2022	SUPPL-15	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761077s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761077Orig1s015ltr.pdf
03/04/2022	SUPPL-14	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761077Orig1s014correctedltr.pdf
05/11/2021	SUPPL-11	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761077s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761077Orig1s011ltr.pdf
02/03/2021	SUPPL-9	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761077s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761077Orig1s009ltr.pdf
04/30/2020	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761077s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761077Orig1s007ltr.pdf
02/15/2020	SUPPL-4	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761077s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761077Orig1s004ltr.pdf
10/04/2019	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761077s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761077Orig1s003ltr.pdf
03/11/2019	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761077s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761077Orig1s001ltr.pdf

Labels for BLA 761077

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/03/2022	SUPPL-15	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761077s015lbl.pdf
09/22/2022	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761077Orig1s017Correctedlbl.pdf
09/22/2022	SUPPL-17	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761077Orig1s017Correctedlbl.pdf
05/11/2021	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761077s011lbl.pdf
02/03/2021	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761077s009lbl.pdf
02/03/2021	SUPPL-9	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761077s009lbl.pdf
02/03/2021	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761077s009lbl.pdf
04/30/2020	SUPPL-7	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761077s007lbl.pdf
04/30/2020	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761077s007lbl.pdf
02/15/2020	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761077s004lbl.pdf
10/04/2019	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761077s003lbl.pdf
10/04/2019	SUPPL-3	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761077s003lbl.pdf
03/11/2019	SUPPL-1	Efficacy-Manufacturing Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761077s001lbl.pdf
05/17/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761077s000lbl.pdf

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