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DEL BOIL-EASE BENZOCAINE STUDY ON SEVEN-DAY USE REQUESTED BY FDA

This article was originally published in The Tan Sheet

Executive Summary

DEL BOIL-EASE BENZOCAINE STUDY ON SEVEN-DAY USE REQUESTED BY FDA at an April 21 "OTC feedback" meeting on the inclusion of benzocaine for the relief of pain associated with boils in the external analgesics monograph, The agency indicated that it would accept Del Pharmaceuticals' petition to allow a 20% benzocaine ointment under the external analgesic monograph with a pain relief indication for boils, However, FDAers questioned the company's proposed dosing of "three-to-four times daily" and seven-day duration of use, given the scope of the data that were submitted to FDA by Del.
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