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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761291
Company: JANSSEN BIOTECH

Medication Guide

REMS

Products on BLA 761291

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TECVAYLI	TECLISTAMAB-CQYV	30MG/3ML(10MG/ML)	INJECTABLE;INJECTION	Prescription	None	No	No
TECVAYLI	TECLISTAMAB-CQYV	153MG/1.7ML(90MG/ML)	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761291

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/25/2022	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761291s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761291Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761291Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/16/2023	SUPPL-5	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761291Orig1s005ltr.pdf
08/09/2023	SUPPL-4	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761291s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761291Orig1s004ltr.pdf
02/20/2024	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761291s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761291Orig1s003ltr.pdf

Labels for BLA 761291

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/20/2024	SUPPL-3	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761291s003lbl.pdf
08/09/2023	SUPPL-4	REMS - MODIFIED - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761291s004lbl.pdf
10/25/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761291s000lbl.pdf

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