Congressmen request BTC information from GAO
WASHINGTON House Energy and Commerce Committee Chairman John Dingell, D-Mich., and Oversight and Investigations Subcommittee Chairman Bart Stupak, D-Mich., have requested an update of the General Accounting Office’s 1995 evaluation on the potential benefits and pitfalls associated with a third-class of drugs in a letter to GAO Comptroller General David Walker, FDANews reported Tuesday.
The FDA held a meeting in October to help identify the issues and hurdles that would need to be addressed if a behind-the-counter class of drugs were to be considered. The FDA has established no timetable for a next step, such as a call for public comments and/or an advisory committee hearing, following that meeting.
The 1995 GAO report on BTC drugs concluded there were no major benefits associated with a third class.
Clinical Products to test-market ExtendBar at So. Cal. retailers
LOS ANGELES Clinical Products on Monday announced the test-market launch of ExtendBar into southern California retailers, including Albertson’s, Ralph’s and Walgreens.
“We believe partnering with Albertsons, Ralphs and Walgreens is a great opportunity for more people to experience the ExtendBar brand and what so many of our loyal, long-time customers have discovered about us,” stated Vijay Chauhan, president of Clinical Products.
ExtendBar is a snack bar specifically formulated to help control blood sugar for up to nine hours, the company claims.
The bar is formulated using slowly metabolizing carbohydrates to extend the release of glucose into the bloodstream.
The product had been developed by Francine Kaufman, past president of the American Diabetes Association.
The Discovery Health Channel recently featured Kaufman’s tour of the world in its documentary “Diabetes: A Global Epidemic.”
Virulite seeks suitor, FDA approval for new cold sore remedy
COSTA MESA, Calif. Virulite, a medical device manufacturer developing a new treatment for cold sores, is looking for a U.S. suitor, having retained Compass Point Capital and Murphy Business and Financial Corporation as its mergers and acquisitions advisors, the U.K. company announced Friday.
Virulite is presently in the process of obtaining Food and Drug Administration clearance for a portable, hand held device that uses an invisible, non-thermal band of near-infrared light that, according to the company, reduces the healing time of cold cores by up to one half.
The company completed a U.S. market test of the product through Walgreens’ online distribution channel, where Virulite outsold all competing cold sore remedies, including the current market leader, the topical cream Abreva by GlaxoSmithKline, Virulite reported.