HEALTH

FDA issues injunction against Wilderness Family Naturals for efficacy claims

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration has issued a permanent injunction against a distributor of dietary supplements, salves and conventional foods, alleging that it made false claims of its products’ ability to treat, cure, mitigate and prevent diseases, the FDA said Tuesday.

The agency alleges that Silver Bay, Minn.-based Wilderness Family Naturals claimed benefits for its products against diseases such as cancer, diabetes, heart disease, arthritis, hyperthyroidism, HIV and AIDS.

The company has signed a consent decree prohibiting it from manufacturing or distributing any products with unapproved claims of benefits against disease. The company has agreed to remove disease claims from its products? labels, labeling and Web sites, as well as references to other Web sites that contain such claims.

“The FDA is acting to product the American public from companies making unapproved disease treatment claims for their products,” FDA acting associate commissioner for regulatory affairs Michael Chappell said in a statement. “Claims made by Wilderness Family might distract consumers from seeking products that have been shown to be safe and effective in treating disease.”

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Perrigo takes license for Clarinex patents, preps for launch of generic

BY Michael Johnsen

ALLEGAN, Mich. Perrigo on Thursday announced that all Hatch-Waxman litigation relating to Schering-Plough’s prescription allergy medicine Clarinex (5 mg) has been settled with Perrigo taking a license under all relevant patents.

Under the terms of the settlement, Perrigo can commercially launch its generic desloratadine product on July 1, 2012, or earlier in certain circumstances. The new product launch may be a prescription or over-the-counter product, depending on its status at the time of launch. The Perrigo product is awaiting FDA approval.

Sales for Clarinex were approximately $300 million, according to Wolters Kluwer data for the twelve months ended Oct. 31, provided by Perrigo.

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Tylenol Warming Taxis provide free rides around Capitol Hill

BY Michael Johnsen

WASHINGTON After visiting New York, Boston and Philadelphia, McNeil Consumer Healthcare is relocating its Tylenol Warming Taxis to the nation’s capital this week, and will offer complimentary cab rides within city limits to Washington residents.

The taxis will be positioned outside select CVS/pharmacy locations from noon through 8 p.m. Dec. 15 through Dec. 21.

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