Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125387
Company: REGENERON PHARMACEUTICALS
Company: REGENERON PHARMACEUTICALS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EYLEA | AFLIBERCEPT | 40MG/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 |
|---|---|---|---|---|---|---|---|
| 11/18/2011 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125387lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125387s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125387s0000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125387Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/14/2023 | SUPPL-84 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125387s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125387Orig1s084ltr.pdf | |
| 09/06/2022 | SUPPL-76 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125387s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125387Orig1s076ltr.pdf | |
| 02/08/2023 | SUPPL-75 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125387s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125387Orig1s075ltr.pdf | |
| 03/30/2021 | SUPPL-69 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125387s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125387Orig1s069ltr.pdf | |
| 05/13/2019 | SUPPL-61 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125387s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125387Orig1s061ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/125387Orig1s061.pdf | |
| 08/12/2019 | SUPPL-60 | Supplement |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125387s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/125387Orig1s060.pdf | |
| 08/16/2018 | SUPPL-58 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125387s056s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125387Orig2s056s058Ltr.pdf | |
| 08/16/2018 | SUPPL-56 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125387s056s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125387Orig2s056s058Ltr.pdf | |
| 05/26/2017 | SUPPL-54 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125387s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125387Orig1s054ltr.pdf | |
| 10/28/2016 | SUPPL-53 | Supplement |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/125387Orig1s053.pdf |
| 10/24/2016 | SUPPL-52 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125387s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125387Orig1s052ltr.pdf | |
| 05/24/2016 | SUPPL-51 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125387s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125387Orig1s051ltr.pdf | |
| 03/25/2015 | SUPPL-48 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125387s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125387Orig1s048ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125387Orig1s048.pdf | |
| 10/06/2014 | SUPPL-43 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125387s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125387Orig1s043ltr.pdf | |
| 07/29/2014 | SUPPL-37 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125387Orig1s037ltr.pdf |
| 07/30/2015 | SUPPL-36 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125387s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125387Orig1s036ltr.pdf | |
| 01/27/2014 | SUPPL-23 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125387s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125387Orig1s023ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125387Orig1s023.pdf | |
| 06/07/2013 | SUPPL-20 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125387s015s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125387Orig1s015,125387Orig1s020ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125387Orig1s020.pdf | |
| 06/07/2013 | SUPPL-15 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125387s015s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125387Orig1s015,125387Orig1s020ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125387Orig1s015.pdf | |
| 09/21/2012 | SUPPL-4 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125387s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125387Orig1s004ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/14/2023 | SUPPL-84 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125387s084lbl.pdf | |
| 12/14/2023 | SUPPL-84 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125387s084lbl.pdf | |
| 02/08/2023 | SUPPL-75 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125387s075lbl.pdf | |
| 09/06/2022 | SUPPL-76 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125387s076lbl.pdf | |
| 03/30/2021 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125387s069lbl.pdf | |
| 08/12/2019 | SUPPL-60 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125387s060lbl.pdf | |
| 05/13/2019 | SUPPL-61 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125387s061lbl.pdf | |
| 08/16/2018 | SUPPL-58 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125387s056s058lbl.pdf | |
| 08/16/2018 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125387s056s058lbl.pdf | |
| 08/16/2018 | SUPPL-56 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125387s056s058lbl.pdf | |
| 05/26/2017 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125387s054lbl.pdf | |
| 10/24/2016 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125387s052lbl.pdf | |
| 05/24/2016 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125387s051lbl.pdf | |
| 07/30/2015 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125387s036lbl.pdf | |
| 03/25/2015 | SUPPL-48 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125387s048lbl.pdf | |
| 10/06/2014 | SUPPL-43 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125387s043lbl.pdf | |
| 01/27/2014 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125387s023lbl.pdf | |
| 06/07/2013 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125387s015s020lbl.pdf | |
| 06/07/2013 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125387s015s020lbl.pdf | |
| 09/21/2012 | SUPPL-4 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125387s004lbl.pdf | |
| 11/18/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125387lbl.pdf |