FDA Approval for REPATHA issued to AMGEN INC
$AMGN
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
Biologic License Application (BLA): 125522
Company: AMGEN INC
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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 08/20/2024 | SUPPL-43 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125522Orig1s043ltr.pdf |
| 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 |
| 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-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 |