FDA Approves Glaxo Non-Prescription Diet Drug

GlaxoSmithKline Consumer Healthcare has said that the FDA approved the weight loss product orlistat capsules for over-the-counter, making it the first non-prescription drug available for this indication in the US.

GlaxoSmithKline claims the drug helps people lose 50% more weight than diet alone. The drug is intended for people 18 and older to use along with a reduced-calorie, low-fat diet and exercise. The recommended dose of orlistat is one 60mg capsule three times a day with meals containing fat.

GSK will market over the counter orlistat under the brand name “alli”. The drug is expected to be available in stores nationwide by summer 2007.

“I applaud the alli program for stressing the importance of a reduced-calorie, low-fat diet in conjunction with a weight-loss medicine proven to be safe and effective. This lines up with research that shows even modest gradual weight loss provides significant health benefits,” commented Caroline Apovian, director of the Center for Nutrition and Weight Management, Boston Medical Center.