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Biologic License Application (BLA): 125387
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 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
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
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125387s056s058lbl.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-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
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