DIPHENHYDRAMINE MONOCITRATE WILL BE CONSIDERED FOR CATEGORY I STATUS
DIPHENHYDRAMINE MONOCITRATE WILL BE CONSIDERED FOR CATEGORY I STATUS as an antishistamine in the OTC final monograph, FDA Associate Com. for Regulatory Affairs Joesph Hile told Rich-Vicks in a recent letter. Reponding to the firm's 1982 petition requesting that diphenhydramine monocitrate be included in the tentative final monograph (TFM) as a Category I antihistamine ingredient, Hile said the administrative record had been closed at the time the petition was submitted and therefore the ingredient could not be addressed in the TFM. The record was re-opened following publication of the OTC antihistamine TFM in January 1985, and Rich-Vick's request concerning diphenhydramine monocitrate has been included, Hile said. He noted that diphenhydramine monocitrate was never previously discussed as a possible ingredient in OTC antihistamine drug products and will be addressed in the final monograph. Rich-Vick's 1982 petition also requested Category I status for diphenhydramine HCl. FDA placed the ingredient in Category I in the OTC antihistamine TFM published last January.
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