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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761028
Company: AMGEN INC

Products on BLA 761028

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761028

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

Labels for BLA 761028

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

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