In the wake of the diet drug rimonabant (Acomplia / Zimulti) debacle on June 13th, there is no need for millions of Americans eager to try Acomplia to look for it under the new name Zimulti.

Barring a miracle, rimonabant will not be approved by the FDA for sale in the United States -- where developer Sanofi-Aventis intended to use the trade name Zimulti -- for at least another two or three years.

In Europe, the Middle East, Latin America, Mexico and all other countries (a total of 38 now) where the drug is either already on sale or where launch is pending, Sanofi's rimonabant will continue to be sold as Acomplia .

It was never Sanofi's idea, of course, to change the name from Acomplia to the rather odd name Zimulti anyway.

The FDA more than two years ago made it clear that it was not going to permit Sanofi to use the name Acomplia, which it thought was too suggestive that the drug would let overweight individuals "acomplish" their weight loss goal.

But while Sanofi heard this message and somehow came up with the name Zimulti for the U.S., the FDA briefing June 13th of the Endocrinologic and Metabolic Drugs Advisory Committee made it clear how Sanofi totally misread the level of concern of FDA staff over safety issues associated with Acomplia.

With new trials unlikely to provide the type of safety data sought by the FDA until the large CRESCENDO study, with 17,000 participants, reports in January 2010, the prospects of the FDA agreeing to some interim analysis that allows Zimulti to come to market earlier seems extremely low.

Hence, if you are in Mexico, various Caribbean islands, or Europe this summer and are hoping to try rimonabant, keep in mind that the name of the drug you are seeking is Acomplia -- not Zimulti.

Source: http://www.acompliareport.com...;