FDA Disappoints On Rimonabant

Rimonabant, perhaps the most anxiously awaited drug in years, has been successful in randomized clinical trials in promoting weight loss and smoking cessation, as well as improving lipid profiles and reducing metabolic syndrome. Last week, in a surprise move, the FDA held back on a blanket approval for rimonabant. Instead, it issued an "approvable" letter to the parent company (Sanofi-Aventis) for weight loss, and a "non-approvable" letter for smoking cessation. Undisclosed requirements were apparently placed on Sanofi before final approval for the weight loss indication is granted. Rimonabant for smoking cessation is apparently in Limbo. Read what this decision means to patients and doctors here.