FDA may approve anti-obesity drug after panel recommendation
The Associated Press
SILVER SPRING, Md. Ÿ A federal advisory panel yesterday narrowly recommended approval for sale in the United States of the first new anti-obesity drug in more than two decades.
The panel for the Food and Drug Administration voted 6-5 to recommend allowing Interneuron Pharmaceuticals Inc. to market the drug, dexfenfluramine.
The FDA usually acts favorably on the recommendations of its scientific panels, but their was no immediate indication when the agency would act on dexfenfluramine.
The drug has been available for sale in 65 countries for the past ten years, but the U.S. panel of experts was concerned about possible adverse side effects of taking the drug over a long period of time.
At the September panel meeting, Interneuron Pharmaceuticals said its dexfenfluramine helped 40 percent of patients in a study lose up to 10 percent of their body weight, twice the amount lost with diet alone.
The drug works by altering the brain chemical serotonin to make people feel full though they have eaten less.
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