said the Food and Drug Administration approved its over-the-counter version of a prescription obesity-fighting drug.
The drug, called Alli, should be available this summer.
Alli is a reduced-strength version of Xenical, which is made and sold by
. Xenical was approved by the FDA in 1999, and Roche will continue to sell the prescription drug.
For investors, Alli has been a
source of anxiety because GlaxoSmithKline's application had been under review for an extended period of time. Two federal advisory panels endorsed the drug 13 months ago, and the FDA granted conditional approval last April.
FDA to approve a switch from prescription to OTC status isn't easy. Companies must convince the agency that
consumers won't abuse a product even in its reduced-potency form.
GlaxoSmithKline said the FDA has approved Alli for overweight people in conjunction with a reduced-calorie, low-fat diet.
"Consumers spend billions of dollars each year on fad diets, unproven miracle pills, and potentially unsafe weight-loss supplements that may not work," the company said Wednesday. "Alli is the clinically proven option to these hyped, quick-fix products that mislead overweight adults away from weight-loss strategies that are backed by medical science."
GlaxoSmithKline announced the FDA's approval after the market closed. In regular trading, the stock slipped 21 cents to $55.35.
"We know that being overweight has many adverse consequences, including an increase in the risk of heart disease and type 2 diabetes," said Dr. Douglas Throckmorton, deputy director for the FDA's Center for Drug Evaluation and Research. Taking Alli "along with diet and exercise, may aid overweight adults who seek to lose excess weight to improve their health."
The drug is targeted at people 18 years of age and older. The drug blocks some of the fat in foods that people eat.
"Consuming a meal with too much fat, while taking Alli, can result in bowel changes such as having an urgent need to use the bathroom," the company said. Bowel problems have been a major side effect for Xenical and a key reason why the prescription drug's sales have been modest.
GlaxoSmithKline said Alli's side effects "generally occur in the first weeks of treatment, are not harmful, and can be managed by following the recommended diet with about 15 grams of fat per meal." The company says Alli users should take a multivitamin once a day at bedtime because the drug can reduce the absorption of some vitamins.
"Because weight loss doesn't happen overnight, we're starting to educate consumers now about the importance of realistic expectations, gradual weight loss and lifestyle changes," said Steven L. Burton, vice president for weight control at the company's consumer products division.