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FDA Stops the Movement of Acomplia and Alli

Millions of obese individuals are waiting anxiously for Acomplia and Alli (pronounced Al-EYE) (low dose Xenical) to enter the market. These pills are expected by summer and with a year passing, there's still no information on these pills regarding its approval by the FDA.

It has now been nine months since the U.S. Food and Drug Administration put a hold on approval of Alli, and observers are starting to wonder if the agency is having second thoughts about making the half-strength version of prescription Xenical (Orlistat) the first FDA-approved over-the-counter weight-loss drug.

As for Acomplia, it has been eleven months since the FDA put a hold on the Sanofi-Aventis diet drug, and the earliest that action seems likely to occur is the end of April.

Professions of optimism from Sanofi and GlaxoSmithKline that their products would soon be on the U.S. market also have largely disappeared. Glaxo, which originally hoped to be putting up displays of Alli in the aisles of pharmacies way back last summer, now is saying nothing about when it hopes to get the diet pill on the market.

The Alli situation is rendered more perplexing by the fact that two FDA advisory committees heard arguments both for and against approving the over-the-counter version of Xenical a year ago, and voted 11-to-3 in favor of non-prescription sale of the drug.

The FDA is not obligated to follow the recommendations of its advisory panels, but it generally does.

No FDA advisory committee meeting, meanwhile, has even been scheduled for Acomplia. Few think that the FDA will act on Acomplia until its Endocrinologic and Metabolic Drugs Advisory Committee weighs in on the issue of the drug's side-effects, and the panel's first meeting of the year is tentatively set for June.

Glaxo had hoped to market Alli as a prescription-quality alternative to unapproved diet supplements sold in health-food stores, drugstores and over the internet, and had said Alli could cost U.S. consumers $12 to $25 a week.

To obtain Acomplia from Europe, Americans are known to pay double the cost which is more than $200. More than half a dozen European countries are selling Acomplia.

There is no information available on its price, though Mexico expects it in the months start.

 
 
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