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

BLOCK DRUG MAY MARKET PROMISE, SENSODYNE-F PENDING APPEAL of a December 1985 court ruling that barred marketing of the toothpastes. Illinois Northern District Court Judge Susan Getzendanner ordered in an April 25 ruling that Block may continue marketing the two products on the condition that labeling include a warning statement alerting consumers to consult a dentist if pain or hypersensitivity persists. Getzendanner's ruling in December upheld FDA's 1983 contention that the Promise and Sensodyne-F combination of potassium nitrate/sodium monofluorophosphate (MFP) made the products unapproved new drugs. Getzendanner explained that while the court believes its ruling will be affirmed on appeal, Block has "made a sufficient showing of likelihood of success on appeal to warrant the grant of a stay." The showing of likelihood of success is based on the fact that although the court found the evidence presented to it "insufficient to satisfy the statutory standards [of safety and efficacy], the evidence was sufficient to support a common-sense conclusion that the product is safe and effective for its intended uses, and to support a finding of general recognition in fact as to safety and effectiveness," Getzendanner stated. Getzendanner also noted that there had been no precedented situation of two safe and effective ingredients combined to form a new product in which: "there is some scholarly recognition of the combined product's safety and effectiveness, no evidence that the combined product is actually unsafe, and no theoretical basis for assuming that the two active ingredients will interact." In her ruling, Getzendanner commented that Block's "failure to obtain the required FDA approval was not a flagrant violation of the statute." She said that "according to defendants' experts, there was no chemical, physical, or physiological basis, as substantiated by human clinical studies, for concluding that the two ingredients will interact to affect the safety or efficacy of either active ingredient." Thus, Getzendanner stated, the generally available scientific literature on the two different ingredients could rationally be extrapolated to form a basis for concluding that the combination found in Promise is also safe and effective." "While the government's experts disputed this assertion," Getzendanner continued, "the court found significant that those experts had no theoretical basis for assuming that the two ingredients would interact with each other." Addressing FDA concerns that the grant of a stay "might encourage other companies to bypass FDA's procedures," Getzendanner stated that "the ruling in this case is a narrow one, limited to the unique situation of the case presented. In the usual case, I will continue to give great weight to the government's interest in maintaining its authority and enforcing compliance with regulatory standards."

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