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's proposed list of Category I OTC antiseptic first aid ingredients includes 10 single agents and four combinations or complexes, according to an Antimicrobial Tentative Final Monograph (TFM) published in the July 22 Federal Register. The TFM proposes an additional 10 single ingredients and seven combinations and complexes for Category III status, requiring additional data to establish effectiveness. Mercury-containing antimicrobials and cloflucarban are Category II ingredients, those not generally recognized as safe and effective, according to the TFM (see chart below for list of FDA's proposed Category I and III ingredients). The July 22 document covers "first aid antiseptic drug products," defined as products which are "applied topically to the skin to help prevent infection in minor cuts, scrapes and burns" ("The Pink Sheet" July 22, T&G-1). The first aid TFM represents FDA's combination of three categories of related products which were considered separately by the OTC Antimicrobial Panel and in a previous Antimicrobial TFM published by FDA in 1978. The agency explained that two other classifications of antimicrobial ingredients -- antimicrobial soaps and antimicrobial cleansing preparations intended for professional use -- will be addressed in future TFMs. One proposed Category III ingredient, triclocarban, was previously classified Category II in the 1978 TFM. However, FDA said it "has reassessed data that were discussed in the [OTC Review] Panel's report . . . in light of the first aid antiseptic category, and is proposing a Category III classification. . . ." 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

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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