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Del, Whitehall benzocaine studies lack reliable toothache relief duration data, FDA says.

This article was originally published in The Tan Sheet

Executive Summary

DEL, WHITEHALL BENZOCAINE STUDIES LACK RELIABLE RELIEF DURATION DATA on toothache pain, FDA concludes in a July 17 "feedback" letter to the Nonprescription Drug Manufacturers Association. In a review of three efficacy studies submitted by Whitehall-Robins on benzocaine as a toothache relief agent and five efficacy trials by Del Pharmaceuticals, FDA states: "The frequency of dosing cannot be predictably determined from these data, especially due to the fact that duration of relief in the studies submitted did not appear to be dose-related."
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