OTC sleep aids get boost from boomers
NEW YORK The market for OTC sleep aids is thriving, thanks in large part to baby boomers, according to a recent research report.
A new report by market research publisher Packaged Facts estimates that the total OTC market for sleep aids alone reached $604 million in 2008, an increase of 9 percent compared with $533 million in 2007. The increase was on par with the 8 percent compound annual growth rate that OTC sleep aids experienced between 2004 and 2008.
Both short-term and long-term success of the market is tied to aging baby boomers, a high-income populace less likely to feel the economic crunch as strongly as consumers with more moderate levels of income, the report states.
Furthermore, women of the baby boomer generation tend to face unique sleep challenges. As women age, more than half entering their menopausal transition years can expect to experience various primary sleep disorders, including sleep apnea, snoring, restless legs syndrome or insomnia.
“Sleep disorders are under-diagnosed in menopausal women, and many experts now recommend special consideration when diagnosing and treating their sleep problems,” stated Tatjana Meerman, publisher of Packaged Facts.
FDA issues injunction against Wilderness Family Naturals for efficacy claims
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.”
Perrigo takes license for Clarinex patents, preps for launch of generic
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.