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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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The combination of hydrocortisone and pramoxine HCl is not safe and effective for OTC anorectal drugs, FDA says in a final rule slated to be published in the Aug. 25 Federal Register. Data provided in support of the ingredients "did not involve a patient population where the product is intended for OTC use, nor were they for the proposed OTC anorectal indication," agency says. There currently are no OTC products that contain the combination, FDA notes. Ferndale Labs requested monograph status for the ingredient combination following release of the 1988 final rule on anorectal products (1"The Tan Sheet" Feb. 14, 1994, p. 8)...

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