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Biologic License Application (BLA): 761077
Company: AMGEN INC
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
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
03/25/2022 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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/25/2022 SUPPL-17 Tentative Approval 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-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761077s009lbl.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
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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