Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

FDA has classified petrolatum as a Category I protectant ingredient for OTC hemorrhoidal products in its OTC Anorectal Drugs Tentative Final Monograph, scheduled for publication in the Federal Register on Aug. 15. Although petrolatum was reviewed as an anorectal product agent, and not a protectant ingredient by FDA's OTC Hemorrhoidal Drugs Panel, the preamble to the TFM notes: "Petrolatum has been placed in Category I by advisory review panels" as an ophthalmic emollient, anorectal agent, and skin protectant. Consequently, the agency proposed a statement of identity for petrolatum as an "anorectal (hemorrhoidal)/skin protectant." On the other hand, the agency reclassified lanolin alcohols to Category III as anorectal protectant ingredients. The panel had recommended lanolin for Category I, FDA noted, even though it had reviewed no products containing the ingredient. In the TFM's combination policy, the agency proposed Category I status for combinations of Category I ingredients "from up to three different therapeutic categories (except protectants)." The panel had recommended such combinations be placed in Category III until final formulation test demonstrate safety and efficacy. FDA said it is "not requiring formulation testing of either single-ingredient or combination anorectal drug products." Comments noted that a number of combinations of Category I single ingredients were consequently recommended for Category III due to lack of final formulation testing. The TFM lists Whitehall's Preparation H ingredient, live yeast cell, in Category III; however, the preamble notes that FDA is currently reviewing results from clinical trials that could move the ingredient to Category I as a wound-healing agent. "Several comments agreed with the panel's minority report that supports the OTC use of live yeast cell derivative as a wound-healing agent," the agency noted. FDA agreed with the panel members that experiments "suggest a positive influence of live yeast cell derivative on wound healing" and show effects like increased oxygen uptake, tissue growth, and epithelization; however, the agency said "there remains a lack of sufficient data on its effectiveness." FDA did not recommend specific vehicles for vasoconstricting ingredients or support a panel recommendation for final formulation testing. The agency said "anorectal active ingredients may be formulated in any safe and suitable vehicle." The preamble urges that ephedrine sulfate and phenylephrine HCl be formulated in vehicles "appropriate for anorectal use" so that the vasoconstrictors are "properly released." Noting that the OTC Hemorrhoidal Drugs Advisory Panel had "concerns about a need for final formulation testing to support safety and effectiveness" and recommended the vasoconstrictors only in aqueous solution, FDA said it "is not proposing the panel's recommendation for final formulation testing." Hydrocortisone was not added to the list of OTC anorectal ingredients, FDA said. Noting that the OTC External Analgesic Drugs TFM, published in 1983, included a label claim for "external anal itching" for hydrocortisone products, the preamble states that hydrocortisone-containing drugs will remain in a single (the external analgesics) rulemaking with the proposed label and not be repeated in the anorectal category. The agency added that the External Analgesics TFM will be amended to require that hydrocortisone products labeled for external anal itching "also be labeled with appropriate general warnings and directions consistent with other OTC anorectal drug products." FDA disagreed with a comment that local anesthetics should be Category I ingredients for intrarectal use, instead of Category III. The preamble notes that the OTC Anorectal Drugs Advisory Panel concluded that "certain local anesthetics, i.e., benzocaine, benzyl alcohol, dyclonine, and pramoxine, could be used safely intrarectally but that data were still needed to establish effectiveness." However, the preamble continues, "this decision does not affect the external use of these ingredients," which were included in the TFM "with appropriate labeling for external use only." Chart omitted.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts