OTC BENZOCAINE/DYCLONINE COMBO IS A NEW DRUG
This article was originally published in The Tan Sheet
Executive Summary
OTC BENZOCAINE/DYCLONINE COMBO IS A NEW DRUG and should be marketed only under an approved NDA, FDA stated in a Nov. 3 letter to SmithKline Beecham. SmithKline had requested that FDA revise the monograph for oral health care drugs to include the combination of benzocaine and dyclonine hydrochloride as safe and effective and allow SB to market the combination prior to a determination that it can be included in the monograph.