The US FDA's joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committees will review GlaxoSmithKline Consumer Healthcare’s New Drug Application for proposed over-the-counter use of orlistat (tetrahydrolipstatin) 60 (mg) capsules in the US, to promote weight loss in overweight adults when used along with a reduced calorie, low-fat diet on January 23, 2006.

John Dent, Senior vice president, research and development, GlaxoSmithKline Consumer Healthcare said, "This advisory committee review is an important step toward a safe and effective OTC weight-loss aid. We have a long and successful history of taking prescription products over-the-counter in a responsible manner, as with NicoDerm CQ and Nicorette and we will work with the FDA to assure appropriate use for OTC orlistat 60 (mg).”

The safety and efficacy of orlistat, which has been available as the prescription drug Xenical (120 mg) in the US since 1999, is supported by more than 100 clinical studies conducted in more than 30 countries, including the four-year landmark XENDOS trial, the longest study ever of a weight loss medicine. More than 21 million people in 145 countries have used orlistat.

GlaxoSmithKline Consumer Healthcare promotes Xenical in the US following an agreement with Roche and has filed an application with the FDA to sell orlistat 60 (mg) over-the-counter. Roche retains marketing rights to orlistat outside of the US.