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

UsernamePublicRestriction
UsernamePublicRestriction

KEY BRANDS REVISING PLAK ATTACK CLAIMS IN ACCORDANCE WITH FDA

Executive Summary

KEY BRANDS REVISING PLAK ATTACK CLAIMS IN ACCORDANCE WITH FDA guidelines, following the receipt of a May 18 regulatory letter that cited Plak Attack Dental Rinse for making plaque treatment and prevention claims. The Irwindale, Calif.-based Key Brands Research Labs planned to submit a response to the reg letter June 19. The firm said it intends to "cooperate fully" with FDA in revising its claims for the oral rinse, which was introduced in January. The FDA reg letter cited the company for failing to comply with FDA's Tentative Final Monograph (TFM) for the Rx-to-OTC switch of fluoride rinses. The agency also noted that the product's ingredients had not been proven safe and effective for plaque removal. * In addition to revising the labeling claims for Plak Attack, Key Brands said it has reshot TV and print ads to comply with FDA regulations and is considering the removal of certain ingredients until further studies prove their efficacy. Plak Attack's active ingredient is .05% sodium fluoride; other ingredients are sanguinaria (bloodroot) extract and sodium benzoate. The current labeling states that the product contains "special ingredients which, upon contact, destroy the bacteria in your mouth, the leading cause of plaque and bad breath." Sanguinaria is the antiplaque ingredient in Vipont Pharmaceuticals' Viadent. * Key Brand's decision to promptly revise its claims contrasts with the response of other oral rinse marketers who have received reg letters for making plaque and/or gingivitis treatment and prevention claims. Warner-Lambert (Listerine), Pfizer/Oral Research Labs (Plax), Vipont and Merrell Dow (Cepacol) are all in the process of defending their claims. In tandem with the recently-issued reg letters, FDA's Action Plan Phase III report reiterates agency intentions to "begin an Advisory Panel review of OTC oral health care drug products bearing antiplaque and antiplaque-related claims, e.g., tartar and gingivitis." The ad budget for Plak Attack is expected to reach $ 5 mil. this year and may increase depending on sales growth, Key Labs said. The firm is projecting first-year volume of $ 40 mil., based on current distribution in 25,000 mass market doors. Print ads have been rescheduled and will appear in eight to 10 August magazines; cable and network TV ads are also planned. Promotions include manufacturer rebates and free-standing-insert coupons.

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

UsernamePublicRestriction

Register

OM011381

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

Cancel