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AllerQuest
AllerQuest

An FDA panel is scheduled to review privately-held AllerQuest LLC’s skin-test kit, whose proposed trade name is PRE-PEN Plus, for the proposed indication to detect the presence of penicillin allergy in patients with a history of penicillin allergy, on March 27, 2019.

PRE-PEN Plus combines the approved product PRE-PEN (benzylpenicilloyl polylysine for injection) with penicillin G potassium, penicilloic acid, penilloic acid, and amoxicillin sodium.

PRE-PEN is the only FDA-approved skin test for the diagnosis of penicillin allergy.