Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761028
Company: AMGEN INC
Company: AMGEN INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MVASI | BEVACIZUMAB-AWWB | 100MG/4ML (25MG/ML) | INJECTABLE; INJECTION | Prescription | None | No | No |
MVASI | BEVACIZUMAB-AWWB | 400MG/16ML (25MG/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 |
---|---|---|---|---|---|---|---|
09/14/2017 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761028s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761028Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761028Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/17/2023 | SUPPL-11 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761028s011lbl.pdf | |
11/15/2021 | SUPPL-8 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761028s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761028Orig1s008ltr.pdf | |
04/19/2021 | SUPPL-6 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761028s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761028Orig1s006ltr.pdf | |
06/24/2019 | SUPPL-4 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761028s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761028Orig1s004ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/17/2023 | SUPPL-11 | Bioequivalence | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761028s011lbl.pdf | |
11/15/2021 | SUPPL-8 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761028s008lbl.pdf | |
04/19/2021 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761028s006lbl.pdf | |
06/24/2019 | SUPPL-4 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761028s004lbl.pdf | |
09/14/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761028s000lbl.pdf |