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    FDA Approval for SELARSDI issued to ALVOTECH USA INC

    10/21/24 10:44:05 PM ET
    $ALVO
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care
    Get the next $ALVO alert in real time by email
    Biologic License Application (BLA): 761343
    Company: ALVOTECH USA INC
    • Email

    Products on BLA 761343

    Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
    SELARSDI USTEKINUMAB-AEKN 45MG/0.5ML INJECTABLE;INJECTION Prescription None No No
    SELARSDI USTEKINUMAB-AEKN 90MG/ML INJECTABLE;INJECTION Prescription None No No

    Approval Date(s) and History, Letters, Labels, Reviews for BLA 761343

    Original Approvals or Tentative Approvals
    Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
    04/16/2024 ORIG-1 Approval N/A Label (PDF)
    Letter (PDF)
    Review
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761343s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761343Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761343Orig1s000TOC.cfm
    Supplements
    Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
    10/18/2024 SUPPL-3 Supplement Letter (PDF)

    Label is not available on this site.

    https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761343Orig1s001, 003ltr.pdf
    10/18/2024 SUPPL-2 Supplement

    Label is not available on this site.

    10/18/2024 SUPPL-1 Supplement Letter (PDF)

    Label is not available on this site.

    https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761343Orig1s001, 003ltr.pdf

    Labels for BLA 761343

    Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
    Patient Package Insert
    Note Url
    04/16/2024 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761343s000lbl.pdf
    Get the next $ALVO alert in real time by email

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