Sanofi Yanks Obesity Drug Application

The weight-loss drug is approved in 42 countries and sold in 20. Analysts had been predicting that it could produce at least $1 billion in annual sales worldwide -- and maybe twice as much, or even more, if it had gained quick approval in the U.S.

Despite approval in big markets such as the European Union, the drug ran into several regulatory roadblocks in the U.S. The initial application to the FDA was filed in April 2005, but the FDA later asked for more information about side effects.

Sanofi-Aventis subsequently said it would initiate a risk-management plan to guard against the drug's use by people with a possibility for depression or "suicidality-related events." Health care regulators at the EU have said they would review psychiatric side-effect information.