U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 761291
Company: JANSSEN BIOTECH
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
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
05/28/2024 SUPPL-8 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761291Orig1s008ltr.pdf
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
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
Back to Top