Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 761028
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
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
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

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