BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P140020 · Supplement: S027 · Decision Apr 26, 2023
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    BRACAnalysis CDx
    PMA Number
    P140020
    Supplement Number
    S027
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 26, 2023
    Date Received
    January 27, 2023
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the change of Zejula® (niraparib) indication from a complementary diagnostic to a companion diagnostic to aid in identifying ovarian cancer patients with deleterious or suspected deleterious germline BRCA1 and BRCA2 mutations, who are or may become eligible for maintenance treatment with Zejula® (niraparib).