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    FDA Approval for ATTRUBY issued to BRIDGEBIO PHARMA INC

    11/25/24 8:41:11 AM ET
    $BBIO
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $BBIO alert in real time by email
    New Drug Application (NDA): 216540
    Company: BRIDGEBIO PHARMA INC
    • Email

    Products on NDA 216540

    Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
    ATTRUBY ACORAMIDIS 712MG TABLET; ORAL Prescription None No No

    Approval Date(s) and History, Letters, Labels, Reviews for NDA 216540

    Original Approvals or Tentative Approvals
    Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
    11/22/2024 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216540s000lbl.pdf

    Labels for NDA 216540

    Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
    Patient Package Insert
    Note Url
    11/22/2024 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216540s000lbl.pdf
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    • FDA Approval for ATTRUBY issued to BRIDGEBIO PHARMA INC

      Submission status for BRIDGEBIO PHARMA INC's drug ATTRUBY (ORIG-1) with active ingredient ACORAMIDIS has changed to 'Approval' on 11/22/2024. Application Category: NDA, Application Number: 216540, Application Classification: Type 1 - New Molecular Entity

      11/25/24 8:41:11 AM ET
      $BBIO
      Biotechnology: Pharmaceutical Preparations
      Health Care