Acomplia May Be Available in Europe or Mexico Before United States .rimonabant mexico

While the timing of FDA approval of Acomplia (rimonabant mexico) for sale in the United States is at this point very much up in the air, Sanofi-Aventis apparently still hopes to launch the highly anticipated weight-loss drug in Europe and Mexico during the second half of this year.Sanofi management, at their meeting with analysts on Feb. 24th, presented a slide show that included a “planned launch schedule” for Acomplia listing the United Kingdom, Ireland, Germany, Sweden, Denmark, Finland and rimonabant mexico as countries where they expect to begin selling the drug in 2006.They also, of course, said they still expect to launch Acomplia in the United States before the end of the year. But the FDA may have different ideas about that, and Sanofi declined to provide any details about issues the U.S. regulatory agency still wants resolved.Interestingly, in the course of a two-hour presentation, not a word was uttered by Sanofi about where Acomplia stands in the European Medicines Agency (EMEA) approval process. An application was submitted to EMEA’s Committee for Medicinal Products for Human Use at about the time it went to the FDA.Sanofi also has not said anything about submission of a marketing application to the Mexican regulatory authority (General Directorate for the Control of Medicinal Products and Technologies Related to Health).Sanofi previously had said it expected rimonabant mexico to be approved by the FDA prior to its approval in Europe, but the FDA’s decision 10 days ago to delay action pending resolution of unspecified issues has put the timing of approval in the U.S. very much in doubt.If Acomplia is placed on the market in Europe prior to approval for sale in the United States, the possibility of bootleg sales of the drug into the U.S. market by internet pharmacies might become a significant FDA concern.Another interesting sidelight is that the French-based pharmaceutical company said it did not plan to launch Acomplia in France until 2007, even though when the EMEA approves a drug, its recommendation is transformed into a single market authorization valid for all 25 European Union countries.Sanofi said it also planned to launch Acomplia in Spain and Italy at about the same time it begins marketing the drug in France, followed by launches later in 2007 in the remainder of Europe. A rollout in other countries around the world would commence in 2008, the company said.
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