Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761049
Company: EMD SERONO INC
Company: EMD SERONO INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BAVENCIO | AVELUMAB | 20MG/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 |
---|---|---|---|---|---|---|---|
03/23/2017 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761049s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761049Orig1s000ltredt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761049Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/26/2024 | SUPPL-20 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761049s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761049Orig1s020ltr.pdf | |
10/11/2024 | SUPPL-19 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761049s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761049Orig1s019ltr.pdf | |
03/06/2024 | SUPPL-16 | Supplement |
Label (PDF)
Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761049s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761049Orig1s016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761049Origs016ltr.pdf | |
09/06/2023 | SUPPL-15 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761049s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761049Orig1s015ltr.pdf | |
07/15/2022 | SUPPL-13 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761049s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761049Orig1s013ltr.pdf | |
06/30/2020 | SUPPL-9 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761049s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761049Orig1s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761049Orig1s009.pdf | |
05/14/2019 | SUPPL-6 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761049s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761049Orig1s006ltr.pdf | |
11/10/2020 | SUPPL-5 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761049s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761049Orig1s005ltr.pdf | |
10/19/2018 | SUPPL-3 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761049s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761049Orig1s003ltr.pdf | |
10/12/2017 | SUPPL-2 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761049s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761049Orig1s002ltr.pdf | |
04/25/2017 | SUPPL-1 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761049Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/26/2024 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761049s020lbl.pdf | |
11/26/2024 | SUPPL-20 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761049s020lbl.pdf | |
10/11/2024 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761049s019lbl.pdf | |
03/06/2024 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761049s016lbl.pdf | |
09/06/2023 | SUPPL-15 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761049s015lbl.pdf | |
07/15/2022 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761049s013lbl.pdf | |
11/10/2020 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761049s005lbl.pdf | |
11/10/2020 | SUPPL-5 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761049s005lbl.pdf | |
06/30/2020 | SUPPL-9 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761049s009lbl.pdf | |
05/14/2019 | SUPPL-6 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761049s006lbl.pdf | |
10/19/2018 | SUPPL-3 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761049s003lbl.pdf | |
10/12/2017 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761049s002lbl.pdf | |
03/23/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761049s000lbl.pdf |