FDA Approval for AIMOVIG issued to AMGEN INC
$AMGN
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
Biologic License Application (BLA): 761077
Company: AMGEN INC
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 |
|---|---|---|---|---|---|
| 08/06/2024 | SUPPL-22 | Supplement |
Label is not available on this site. |
||
| 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 |
| 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-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 |