Whitehall Labs
This article was originally published in The Tan Sheet
Executive Summary
Anbesol manufacturer notifies FDA in Dec. 9 letter of the present status of three studies generating data in support of benzocaine as an OTC toothache reliever. Whitehall noted that one study has been abandoned, while a second is complete with a study report pending, and a third is ongoing. The ongoing study, enrolling 60 subjects out of a proposed 100, is expected to be finished by month's end. Responding to a September 1991 Federal Register notice declaring that insufficient data existed to classify benzocaine in Category I, Whitehall "projects submission of outstanding supportive clinical data by Feb. 28"...