Perrigo begins shipping OTC ibuprofen and diphenhydramine citrate tablets
ALLEGAN, Mich. Perrigo on Friday announced that the company has begun shipping over-the-counter ibuprofen and diphenhydramine citrate tablets, 200/38 mg. The product will be marketed under store brand labels and is comparable to Wyeth Consumer Healthcare’s Advil PM tablets, 200/38 mg, indicated as a pain reliever/nighttime sleep-aid.
Estimated brand sales for the product for the last 12 months ending Sept. 28 were $70 million, according to Perrigo estimates.
Missouri Senate committee considers reverse-switch of PSE
JEFFERSON CITY, Mo. A Missouri Senate committee on Monday entertained legislation that would mandate the reverse-switch of all products containing ephedrine, pseudoephedrine or phenylpropanolamine — all products currently sold and tracked from behind the pharmacy counter per the Combat Meth Act.
The bill would exempt dietary supplements containing naturally-occurring ephedrine alkaloids that constituted less than 15% of the total weight of the supplements; however, supplements containing ephedrine have been banned from sale by the Food and Drug Administration since 2004. PSE and PPA are drugs, and therefore cannot be legally sold as supplements. PPA is also no longer available for sale OTC — the FDA requested that PPA products be pulled from the market in 2000.
That leaves only PSE products that are currently available in drug stores, and if the legislation passes this year, PSE products will become prescription-only drugs througout the state.
The move would limit access to PSE, critics charge, and would force consumers with nothing more than a common cold out of their local drug stores and into their local doctor’s offices.
Oregon switched PSE to prescription-only in 2006, and have since claimed that the move has nearly eliminated methamphetamine labs.
Part of the impetus behind the bill may be financial. The state has yet to release funds to support electronic logbook requirements on the sale of PSE, according to published reports, and switching PSE to prescription-only status would relieve the legislature from that financial burden.
American Herbal Products Association launches Foundation Web site
SILVER SPRING, Md. The American Herbal Products Association has announced the debut of www.AHPAFoundation.org, the Web page for the AHPA Foundation for Education & Research on Botanicals designed to provide companies and individuals with an easy way to support the Foundation’s substantive revision of the American Herbal Products Association’s Botanical Safety Handbook through online donation.
“The Botanical Safety Handbook provides both a clinically-relevant assessment of the safety of numerous herbs in commerce and invaluable data to assist manufacturers in developing labels that adequately inform consumers,” stated AHPA-ERB Foundation chairman and Neways International senior director of regulatory affairs, Monzur Ahmed. “It is imperative for industry that the Botanical Safety Handbook contains the most recent and comprehensive information available, and now the ability for companies to financially contribute online provides a convenient way to support this new edition of the Handbook.”
First published in 1997, the Botanical Safety Handbook has become a reference text for healthcare providers, consumers, retailers and manufacturers of herbal products. The text provides safety information on more than 600 species of plants known to be in trade as ingredients in dietary supplements, and, employing a unique safety rating system, classifies each species listed based on a review of a number of authoritative contemporary botanical references and knowledge of historical use.
“While many health care providers in the U.S. believe research on botanicals is scarce, in actuality a wealth of information is obtainable, but not easily accessible since it is scattered in various academic journals and texts on the clinical use of botanicals,” stated Zoe Gardner, program coordinator of the Medicinal Plants Program at the University of Massachusetts and research editor of the Botanical Safety Handbook revision. “An accurate, scientifically-based assessment of herbal ingredients will be required for medical professionals to accept the use of health-promoting botanicals.”