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

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.