Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125559
Company: REGENERON PHARMACEUTICALS
Company: REGENERON PHARMACEUTICALS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PRALUENT | ALIROCUMAB | 75MG | INJECTABLE;INJECTION | Prescription | None | TBD | No |
| PRALUENT | ALIROCUMAB | 150MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/24/2015 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125559Orig1s000lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125559Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125559Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/09/2025 | SUPPL-47 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125559s047lblcorrection.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125559Orig1s047Correctedltr.pdf | |
| 03/08/2024 | SUPPL-39 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125559s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125559Orig1s039ltr.pdf | |
| 04/01/2021 | SUPPL-30 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125559s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125559Orig1s029,s030ltr.pdf | |
| 04/01/2021 | SUPPL-29 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125559s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125559Orig1s029,s030ltr.pdf | |
| 03/10/2020 | SUPPL-24 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125559s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125559Orig1s024ltr.pdf | |
| 04/26/2019 | SUPPL-20 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125559s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125559Orig1s019, s020ltr.pdf | |
| 04/26/2019 | SUPPL-19 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125559s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125559Orig1s019, s020ltr.pdf | |
| 11/06/2018 | SUPPL-18 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125559s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125559Orig1s018ltr.pdf | |
| 07/20/2018 | SUPPL-15 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125559s015lbl.pdf | |
| 08/22/2018 | SUPPL-14 | Supplement |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125559s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125559Orig1s014Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/125559Orig1s014TOC.cfm | |
| 09/20/2017 | SUPPL-6 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125559s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125559Orig1s006ltr.pdf | |
| 07/27/2017 | SUPPL-2 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125559s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125559Orig1s002ltr.pdf | |
| 04/24/2017 | SUPPL-1 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125559s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125559Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/09/2025 | SUPPL-47 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125559s047lblcorrection.pdf | |
| 03/08/2024 | SUPPL-39 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125559s039lbl.pdf | |
| 04/01/2021 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125559s029s030lbl.pdf | |
| 04/01/2021 | SUPPL-30 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125559s029s030lbl.pdf | |
| 04/01/2021 | SUPPL-29 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125559s029s030lbl.pdf | |
| 03/10/2020 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125559s024lbl.pdf | |
| 03/10/2020 | SUPPL-24 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125559s024lbl.pdf | |
| 04/26/2019 | SUPPL-20 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125559s019s020lbl.pdf | |
| 04/26/2019 | SUPPL-19 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125559s019s020lbl.pdf | |
| 11/06/2018 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125559s018lbl.pdf | |
| 08/22/2018 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125559s014lbl.pdf | |
| 07/20/2018 | SUPPL-15 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125559s015lbl.pdf | |
| 07/20/2018 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125559s015lbl.pdf | |
| 09/20/2017 | SUPPL-6 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125559s006lbl.pdf | |
| 07/27/2017 | SUPPL-2 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125559s002lbl.pdf | |
| 04/24/2017 | SUPPL-1 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125559s001lbl.pdf | |
| 07/24/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125559Orig1s000lbledt.pdf |