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Sanofi Says U.S. Acomplia Launch Still On Track

Sanofi-Aventis reiterated on Friday that its anti-obesity pill Acomplia was on track for launch in the United States before the end of 2006, as shares in the drugmaker slipped on concerns over the project.

A spokesman for the world's third-largest drugmaker said the company was in constant discussion with the U.S. Food & Drug Administration (FDA) about Acomplia and that there was no change to what Sanofi had said about the issue on August 2.

The French drugmaker said then that it remained hopeful and confident it could launch Acomplia in the United States before the end of this year.

Earlier on Friday news agency Bloomberg said that Sanofi was amassing data on European patients using Acomplia that could help persuade U.S. regulators that the product was safe.

Sanofi shares were down 2.1 percent in early afternoon trade, as analysts said the article raised concerns that Sanofi had to provide more data to get Acomplia approved by the FDA than was previously thought.

Aurel Leven analyst Jerome Berton said it seemed more difficult now for Sanofi to get FDA approval for Acomplia by the fourth quarter of 2006, and added it might not get the necessary approval until the first quarter of 2007.

Source:http://today.reuters.com