Approvals (Drugs@FDA)

TEVIMBRA

BEIGENE · islelizumab-jsgr

BLA761380Biologic (BLA)Prescription
Open FDA's page for this record
Application number
BLA761380
Sponsor name
BEIGENE
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250303
    Review priority
    STANDARD
    Submission class code
    TYPE 9- BLA
    Submission class code description
    Type 9 - New indication submitted as distinct BLA, consolidated
    Submission property type
    1. Code
      Orphan
    Application docs
    1. ID
      81437
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761380Orig1s000ltr.pdf
      Date
      20250304
      Type
      Letter
    2. ID
      81438
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761380s000lbl.pdf
      Date
      20250305
      Type
      Label
    3. ID
      81439
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761380s000lbl.pdf#page=26
      Date
      20250305
      Type
      Medication Guide
    4. ID
      84146
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761380Orig1s000TOC.html
      Date
      20251113
      Type
      Review
Products
  1. Product number
    001
    Reference drug
    TBD
    Brand name
    TEVIMBRA
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Active ingredients
    1. Name
      islelizumab-jsgr
      Strength
      10 mg/mL
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.