February 21, 2006
FDA nixes Acomplia smoking indication but may approve drug for weight loss
The FDA declined approving Sanofi-Aventis’ highly anticipated Acomplia (rimonabant) for smoking cessation but may give a green light to the drug for weight loss, the French drugmaker said in a statement on Friday.
The Sanofi statement said the FDA issued the manufacturer an “approvable” letter outlining what it must do to win approval of Acomplia for weight loss.
Neither Sanofi nor the FDA disclosed the conditions that must be met before the agency will let the company sell Acomplia in the US.
“Sanofi-Aventis will continue to work in close collaboration with the FDA,” the company's statement said.