Later this month an expert panel of the FDA will take up GlaxoSmithKline's application to sell the obesity drug Xenical over-the-counter. If it gets a green light, GSK will have the first prescription obesity drug to go OTC. Analysts note, however, that the FDA can often prove hesitant about approving prescription drugs for OTC use, as Merck found out last year with its OTC application for the cholesterol-lowering Mevacor. Xenical is a 'behind-the-counter" drug in Australia and New Zealand, a special third category that the U.S. doesn't recognize. Xenical works by preventing the body from absorbing about a third of dietary fat from being absorbed by the intestine. GSK licensed the U.S. OTC rights from Roche, which had been selling the drug in the U.S. Xenical sales have faded in recent years, along with other prescription obesity drugs, over fears of possible side effects and limited results.
- read this article from USA Today for more information