Anorectal combo non-monograph
This article was originally published in The Tan Sheet
Executive Summary
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)...