GSK's orlistat 60mg gets FDA OK for OTC

The Consumer Healthcare division of UK pharmaceutical major GlaxoSmithKline says that the US Food and Drug Administration has approved its weight loss drug orlistat 60mg capsules for over-the-counter sale. The firm added that the agent, which will be marketed under the brand name alli, is approved when used in conjunction with a reduced-calorie, low-fat diet, and has been shown to help people lose up to 50% more weight than dieting alone.

The FDA explained that orlistat is not a treatment for people who have problems absorbing food, or those that are not overweight. The agency went on to say that the drug helps produce weight loss by reducing the intestinal absorption of fat, but added that, due to the possible loss of nutrients, it recommended the use of the product in conjunction with multivitamins.

Roche's Xenical (orlistat 120mg capsules) will still be available on prescription for those who require physician directed treatment.