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HYDROCORTISONE/PRAMOXINE COMBINATION FOR ANORECTAL ITCH IS NON-MONOGRAPH

This article was originally published in The Tan Sheet

Executive Summary

HYDROCORTISONE/PRAMOXINE COMBINATION FOR ANORECTAL ITCH IS NON-MONOGRAPH and requires clinical studies showing the effectiveness of both ingredients as a combination drug product, FDA told Ferndale Laboratories' attorney Gary Yingling of the Washington, D.C. firm McKenna & Cuneo. In a Jan. 13 letter, FDA said it has "determined that the data and information do...not provide sufficient evidence to demonstrate that each of the active ingredients in the combination product contributes to the claimed effects."
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