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Pre-Pen Plus (Benzylpenicilloyl Polylysine) & Skin Test Antigen Utilization

    Basic Details
    Last Updated
    Wednesday, February 21, 2024
    Original Posting Date
    Health Outcome(s)
    skin test antigen utilization
    Drug Use
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    A U.S. Food and Drug Administration (FDA) Advisory Committee (AC) meeting was planned to discuss the application for a new Penicillin Allergy Skin Test Kit (Pre-Pen Plus) product in March 2019. In preparation for the AC meeting, FDA used Sentinel to consider background information on trends in the recent use of penicillin allergy skin testing generally. The Sentinel analysis provided an estimate of the increasing trend in Pre-Pen penicillin allergy testing between 2008 and 2018. Ultimately, for reasons unrelated to the Sentinel analysis, FDA canceled the planned AC meeting.