A government advisory panel voted that the FDA should allow the over-the-counter sale of orlistat – a drug currently sold by prescription by GlaxoSmithKine PLC under the brand name Xenical. If approved by the FDA itself, it will appear as Alli at a drugstore near you.
A pill that helps block fat absorption in the body moved closer to becoming the nation’s first federally approved over-the-counter diet pill on Monday.
A panel of government health advisers recommended in an 11-3 vote that the Food and Drug Administration allow the pill’s maker to sell it without the need of a doctor’s prescription.
The FDA usually follows recommendations of advisory panels such as it received Monday.
FDA approval would mean the 60-milligram over-the-counter version of the drug could be on the market by this summer.
The drug is hardly a magic bullet even by the drug company’s own admission. In six-month clinical trials obese people who took orlistat lost on average 5.3 pounds to 6.2 pounds more than did those who were given dummy pills.
GlaxoSmithKline wants people to use it for only six months at a time, but as an over-the-counter item its use would not be policed.
“There is no magic pill for weight loss and orlistat is definitely not a magic pill,” John Dent, a research and development executive at Glaxo, said at the FDA advisory committee’s meeting in Bethesda, Md. “Orlistat is a tool that will help people control their calorie intake.”
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