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GlaxoSmithKline said new data from a study found a 60 mg. low-dose version of its weight-loss medication Xenical (orlistat) to be safe, effective and tolerable in overweight individuals. Glaxo bought U.S. marketing rights for Xenical from Roche earlier this year and is planning to market an OTC version of the drug.
Currently there are no FDA-approved OTC weight loss drugs on the U.S. market and only a handful of drugs available with a prescription, including Abbott Laboratories' Meridia (sibutramine). Xenical is currently marketed to obese and overweight people who have health problems such as diabetes or high blood pressure.
The FDA is expected to make a decision sometime around March following a likely public meeting of outside medical experts to make a recommendation about whether an OTC switch should be allowed.
Meanwhile, the FDA is also expected to make a decision on Accomplia (rimonabant), a new type of proposed prescription weight-loss drug from Sanofi-Aventis, by the end of the first quarter of 2006. The drug is designed to block a chemical in the body believed to influence weight gain and smoking.