FDA joint advisory committee gives nod to OTC orlistat

January 30, 2006

The FDA's joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee voted 11 to 3 to recommend approval of GlaxoSmithKline's orlistat 60-mg capsules for over-the-counter use in the U.S. OTC orlistat, which would be marketed under the brand name Alli, would be the only FDA-approved weight-loss medication available OTC. Alli would be indicated for use by overweight adults along with a reduced-calorie, low-fat diet. Xenical (orlistat 120-mg capsules) will remain available by prescription for obesity management and for those who should be under the care of a physician.