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    FDA Approval for XOLREMDI issued to X4 PHARMACEUTICALS INC

    4/29/24 2:36:51 PM ET
    $XFOR
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care
    Get the next $XFOR alert in real time by email
    New Drug Application (NDA): 218709
    Company: X4 PHARMACEUTICALS INC
    • Email

    Products on NDA 218709

    Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
    XOLREMDI MAVORIXAFOR 100MG CAPSULE;ORAL Prescription None No No

    Approval Date(s) and History, Letters, Labels, Reviews for NDA 218709

    Original Approvals or Tentative Approvals
    Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
    04/26/2024 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
    Letter (PDF)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218709s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218709Orig1s000ltr.pdf

    Labels for NDA 218709

    Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
    Patient Package Insert
    Note Url
    04/26/2024 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218709s000lbl.pdf
    Get the next $XFOR alert in real time by email

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