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

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."