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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761342
Company: JANSSEN BIOTECH

Medication Guide

REMS

Products on BLA 761342

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TALVEY	TALQUETAMAB-TGVS	3MG/1.5ML(2MG/ML)	INJECTABLE;INJECTION	Prescription	None	No	No
TALVEY	TALQUETAMAB-TGVS	40MG/ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761342

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/09/2023	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761342s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761342Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761342Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/02/2025	SUPPL-16	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761342s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761342Orig1s016ltr.pdf
08/19/2025	SUPPL-15	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761342Orig1s015ltr.pdf
12/02/2024	SUPPL-12	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761291Orig1s011,761342Orig1s012ltr.pdf
07/02/2024	SUPPL-5	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761291Orig1s007,761342Orig1s005ltr.pdf
02/20/2024	SUPPL-4	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761342Orig1s004ltr.pdf
11/16/2023	SUPPL-1	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761342Orig1s001ltr.pdf

Labels for BLA 761342

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/02/2025	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761342s016lbl.pdf
10/02/2025	SUPPL-16	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761342s016lbl.pdf
08/09/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761342s000lbl.pdf

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