Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125522
Company: AMGEN INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REPATHA EVOLOCUMAB 140MG/ML 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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125522s019lbl.pdf
02/15/2019 SUPPL-19 Labeling-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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