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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761210
Company: JANSSEN BIOTECH

Products on BLA 761210

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RYBREVANT	AMIVANTAMAB-VMJW	350MG/7ML(50MG/ML)	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761210

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/21/2021	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761210s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761210Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761210Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/01/2024	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761210s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761210Orig1s003ltr.pdf
11/04/2022	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761210s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761210Orig1s002ltr.pdf
12/21/2021	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761210s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761210Orig1s001ltr.pdf

Labels for BLA 761210

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/01/2024	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761210s003lbl.pdf
11/04/2022	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761210s002lbl.pdf
12/21/2021	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761210s001lbl.pdf
05/21/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761210s000lbl.pdf

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