FDA Rejects Sanofi-Aventis Drug Application

Law360, New York (September 1, 2006, 12:00 AM EDT) -- Pharmaceutical giant Sanofi-Aventis suffered a blow this week when the U.S. Food and Drug Administration refused to approve its cardiovascular drug, Multaq.

The FDA issues letters when company applications don’t adequately demonstrate a drug’s safety or efficacy. Sanofi-Aventis didn't say why Multaq, which the company hopes will be a blockbuster, was rejected.

Sanofi-Aventis, the world’s third-largest pharmaceutical company, said it would refile an application for the drug at the beginning of next year. The company is hoping to bolster its case with clinical data from an...
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