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FDA has not asked for acomplia performance data October 07, 2006 On Oct. 6 Sanofi-Aventis had denied that FDA has asked for more safety data which was gathered by Sanofi to track the side effects of diet drug Acomplia in Europe .This data can be helpful to approve the diet-pill for sale in the United States. The chief medical officer Doug Greene pointed out that side effect of diet drug acomplia on the patients remains alarmed for FDA. A trial had already been conducted out on 13000 patients to find out the side effects of diet drug Acomplia. Sanofi spokesperson said” We have not been asked by the FDA for this data." Greene had marked that the FDA has become very careful about approving the diet drug after getting experience in the recent years by approving the diet drug in combination with Fen-phen which was found dangerous for some patients. Greene said "We're working very closely with them and helping them in their interpretation of the data. We think when it completes its review, Acomplia will be found to be safe and effective. '' The observers of FDA has considered that Greene’s remarks are more realistic rather than Sanofi’s Friday’s statement which includes that Acomplia will be on the market in the U.S. before the end of 2006.
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